Anxiety, Chemotherapy-induced Nausea and Vomiting
Conditions
Keywords
stem cell transplant, anxiety, chemotherapy-induced nausea and vomiting, aromatherapy
Brief summary
The purpose of this study is to evaluate the effect of inhaled aromatherapy on symptoms of nausea/vomiting and anxiety in patients who have received a stem cell transplant. Aromatherapy involves essential oils from aromatic plants that can be absorbed into the body in different ways. Our study will be using inhaled aromatherapy, which has been found helpful for symptoms such as nausea/vomiting and anxiety.
Detailed description
The purpose of this study is to evaluate the efficacy of aromatherapy on symptoms of chemotherapy-induced nausea, vomiting, and retching (CINVR) and anxiety for patients hospitalized for hematopoietic stem cell transplant. The primary aim will be to evaluate the effect of inhaled aromatherapy on CINVR and anxiety symptoms compared to control for 48 hours. Secondary aims include (1) Evaluating patient satisfaction with aromatherapy at completion of study; (2) Evaluating the antiemetic administration between intervention and control groups during the 48-hour intervention time span; (3) Evaluating the number and incidence of unit falls pre and post intervention. This study will be a randomized controlled trial. Prior to randomization, participants will be asked which symptom, nausea/vomiting or anxiety, is most burdensome for them. Participants will be stratified based on their identified symptom of burden (nausea/vomiting or anxiety) and will then be randomized to either the intervention or control group, with a target of 50 participants in the nausea/vomiting symptom group (25 intervention and 25 control) and 50 participants in the anxiety symptom group (25 intervention and 25 control). Intervention and control groups will receive Wyndmere Naturals, Inc. aromatherapy patches and a symptom diary. Participants in the intervention group indicating that nausea/vomiting is the primary symptom of concern will receive peppermint inhaled aromatherapy patches (or mandarin if peppermint intolerance indicted). Participants in the intervention group indicating that anxiety is the primary symptoms of concern with receive lavender inhaled aromatherapy patches. The control group will receive non-scented aromatherapy patches (i.e., blank hydrogel adhesive patches without essential oil infusion), so it will not be feasible to blind participants to group assignment. The control group will have the same interactions with the study team as the intervention group and will complete patch changes and a symptom diary to serve as an attention control.
Interventions
DRUGEssential oils
Participants will receive Wyndmere Naturals, Inc. aromatherapy patches. The hydrogel adhesive patches are infused with essential oil for inhaled aromatherapy treatment. The aromatherapy patches provide an occlusive barrier that is hypoallergenic, allowing essential oils to be inhaled without coming in direct contact with the skin. Participants indicating nausea/vomiting is their symptom of concern will receive peppermint aromatherapy patches (or mandarin if peppermint sensitivity). Participants indicating anxiety is their symptom of concern will receive lavender aromatherapy patches.
DRUGPlacebo
Patients assigned to either control group (nausea/vomiting or anxiety) will receive Wyndmere Naturals non-scented patches (i.e., blank hydrogel adhesive patches without essential oil infusion).
Sponsors
Indiana University Health
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
Participants will not be informed of assignment to intervention or control; however, the blank aromatherapy patch (control group) will not have a scent and the essential oil infused aromatherapy patch (intervention group) will. Thus, it may be obvious to participants what group they are randomized to.
Intervention model description
Prior to randomization, participants will be asked which symptom, nausea/vomiting or anxiety, is most burdensome for them. Participants will be stratified based on their identified symptom of burden (nausea/vomiting or anxiety) and will then be randomized to either the intervention or control group, with a target of 50 participants in the nausea/vomiting symptom group (25 intervention and 25 control) and 50 participants in the anxiety symptom group (25 intervention and 25 control).
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Patients from a bone marrow transplant unit or hematology/oncology unit within an adult academic health center in the Midwest. * Adult stem cell transplant inpatients that have received autologous or allogeneic transplant and are actively going through therapy. * Patients must also be alert and oriented, able to interact with the study team, and able to read and write English.
Exclusion criteria
* Under 18 years of age * Intubation * Medical sedation * Receipt of chimeric antigen receptor T (CAR-T) cells * History of atrial fibrillation * History of seizures/epilepsy * Adhesive allergy or sensitivity * Currently pregnant * Prisoner
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Chemotherapy-induced Nausea, Vomiting, and Retching (CINVR) Symptoms at Baseline, 25 Hours, and 48 Hours | baseline (0 hours) and post-intervention (24, 48 hours) | CINVR involves three gastrointestinal symptoms (nausea, vomiting, retching) influenced by administration of chemotherapy. Nausea is expressed as an unpleasant feeling in the throat/epigastrium that can result in expulsion of stomach content, known as vomiting. Retching is the effort to expel stomach contents without success. The Rhodes Index of Nausea, Vomiting and Retching (INVR) was used to measure CINVR and includes 8 Likert-type items on a 5-point scale. Items are scored from 0 (least amount of distress) to 4 (the most distress) and added after reverse coding items 1,3,6, and 7 to calculate an overall INVR score. The overall score ranges from 0 to 32, with higher scores indicating higher symptom burden. Subscales for symptom experience, occurrence, and distress for each symptom (nausea, vomiting, retching) are calculated by adding corresponding scale items for each subscale. The ranges for each subscale were as follows: nausea experience (0-12), vomiting experience (0-12), |
| Anxiety Symptoms at Baseline 24 Hours, and 48 Hours | baseline (0 hours) and post-intervention (24, 48 hours) | Anxiety is defined as excessive or persistent worry about aspects of life. Anxiety was measured using a shortened version of Spielberger's State Anxiety Inventory (SAI). The original SAI contains 20 items to measure state anxiety and items are scored using a 4-point Likert-type scale (almost never-almost always). The shortened SAI retains 6 items (from the original 20) and has evidence supporting good internal reliability consistency and strong construct validity. Items are scored from 1 (not at all) to 4 (very much so) and added after reverse coding anxiety absent items, with higher total scores indicating higher state anxiety. The shortened SAI total score ranges from a total score of 6-24. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction at 48 Hours | post-intervention (48 hours) | An investigator-developed questionnaire was administered at the 48-hour study completion to evaluate patient satisfaction. Participants rated their satisfaction with the intervention on a 1-10 rating scale, with 10 being extremely satisfied (e.g., higher score means higher satisfaction). |
| Medications Administered for Nausea/Vomiting Indication for 48 Hour Study Timeframe | 48 hour intervention timeframe | Medications administered for nausea/vomiting indication (scopolamine, lorazepam, promethazine, prochlorperazine, olanzapine, dexamethasone, Marinol, ondansetron). Medications administered for nausea/vomiting symptom indication were extracted from the electronic medical record for participants in the nausea/vomiting symptom group. |
| Inpatient Fall Events at Baseline and During Intervention | baseline (December 2020-February 2022) and during intervention (March 2022-June 2023) | Fall numbers using total number of falls reported to the National Database of Nurse Quality Indicators. Data were extracted from the bone marrow transplant and hematology/oncology units for baseline (December 2020-March 2022) and intervention (March 2022-June 2023) timeframes. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention - Nausea/Vomiting Patients indicating that nausea/vomiting is their primary symptom of concern and are randomized to receive intervention will be allocated to the intervention - nausea/vomiting arm. This arm will receive peppermint inhaled aromatherapy patches (or mandarin as an alternative if they have a peppermint sensitivity).
Essential oils: Participants will receive Wyndmere Naturals, Inc. aromatherapy patches. The hydrogel adhesive patches are infused with essential oil for inhaled aromatherapy treatment. The aromatherapy patches provide an occlusive barrier that is hypoallergenic, allowing essential oils to be inhaled without coming in direct contact with the skin. Participants indicating nausea/vomiting is their symptom of concern will receive peppermint aromatherapy patches (or mandarin if peppermint sensitivity). Participants indicating anxiety is their symptom of concern will receive lavender aromatherapy patches | 24 |
| Intervention - Anxiety Patients indicating that anxiety is their primary symptom of concern and are randomized to receive intervention will be allocated to the intervention - anxiety arm. This arm will receive lavender inhaled aromatherapy patches.
Essential oils: Participants will receive Wyndmere Naturals, Inc. aromatherapy patches. The hydrogel adhesive patches are infused with essential oil for inhaled aromatherapy treatment. The aromatherapy patches provide an occlusive barrier that is hypoallergenic, allowing essential oils to be inhaled without coming in direct contact with the skin. Participants indicating nausea/vomiting is their symptom of concern will receive peppermint aromatherapy patches (or mandarin if peppermint sensitivity). Participants indicating anxiety is their symptom of concern will receive lavender aromatherapy patches. | 21 |
| Control - Nausea/Vomiting Patients indicating that nausea/vomiting is their primary symptom of concern and are randomized to receive control will be allocated to the control - nausea/vomiting arm. This arm will receive blank (no essential oil infusion) aromatherapy patches.
Placebo: Patients assigned to either control group (nausea/vomiting or anxiety) will receive Wyndmere Naturals non-scented patches (i.e., blank hydrogel adhesive patches without essential oil infusion). | 26 |
| Control - Anxiety Patients indicating that anxiety is their primary symptom of concern and are randomized to receive control will be allocated to the control - anxiety arm. This arm will receive blank (no essential oil infusion) aromatherapy patches.
Placebo: Patients assigned to either control group (nausea/vomiting or anxiety) will receive Wyndmere Naturals non-scented patches (i.e., blank hydrogel adhesive patches without essential oil infusion). | 21 |
| Total | 92 |
Baseline characteristics
| Characteristic | Intervention - Nausea/Vomiting | Total | Control - Anxiety | Control - Nausea/Vomiting | Intervention - Anxiety |
|---|---|---|---|---|---|
| Age, Continuous | 55 Years | 52 Years | 51 Years | 52 Years | 51 Years |
| Cancer Type Dendritic Cell | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Cancer Type Germ Cell Tumor | 3 Participants | 10 Participants | 1 Participants | 4 Participants | 2 Participants |
| Cancer Type Hodgkin's Disease | 0 Participants | 6 Participants | 3 Participants | 0 Participants | 3 Participants |
| Cancer Type Leukemia | 1 Participants | 12 Participants | 4 Participants | 4 Participants | 3 Participants |
| Cancer Type Multiple Myeloma | 20 Participants | 60 Participants | 11 Participants | 16 Participants | 13 Participants |
| Cancer Type Myelodysplastic Syndromes | 0 Participants | 2 Participants | 2 Participants | 0 Participants | 0 Participants |
| Cancer Type Non-Hodgkin's Lymphoma | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Chemotherapy Regimen BEAM | 0 Participants | 6 Participants | 2 Participants | 1 Participants | 3 Participants |
| Chemotherapy Regimen Etoposide/Carboplatin | 3 Participants | 10 Participants | 1 Participants | 4 Participants | 2 Participants |
| Chemotherapy Regimen Fludarabine/Cytoxan | 0 Participants | 4 Participants | 3 Participants | 1 Participants | 0 Participants |
| Chemotherapy Regimen Fludarabine/Cytoxan/Total Body Irradiation | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Chemotherapy Regimen Melphalan | 20 Participants | 60 Participants | 11 Participants | 16 Participants | 13 Participants |
| Chemotherapy Regimen Thiotepa/Cytoxan | 1 Participants | 10 Participants | 4 Participants | 2 Participants | 3 Participants |
| Chemotherapy Regimen Triptycene/Cytoxan/Fludarabine | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian or Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 4 Participants | 12 Participants | 2 Participants | 3 Participants | 3 Participants |
| Race/Ethnicity, Customized Latino | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Native American or American Indian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Prefer Not to Say | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White/Non-Hispanic | 20 Participants | 78 Participants | 19 Participants | 22 Participants | 17 Participants |
| Sex: Female, Male Female | 17 Participants | 55 Participants | 12 Participants | 10 Participants | 16 Participants |
| Sex: Female, Male Male | 7 Participants | 37 Participants | 9 Participants | 16 Participants | 5 Participants |
| Transplant Type Allogenic | 1 Participants | 16 Participants | 7 Participants | 5 Participants | 3 Participants |
| Transplant Type Autologous | 23 Participants | 76 Participants | 14 Participants | 21 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 21 |
| other Total, other adverse events | 9 / 24 | 12 / 21 |
| serious Total, serious adverse events | 0 / 24 | 1 / 21 |
Outcome results
Primary
Anxiety Symptoms at Baseline 24 Hours, and 48 Hours
Anxiety is defined as excessive or persistent worry about aspects of life. Anxiety was measured using a shortened version of Spielberger's State Anxiety Inventory (SAI). The original SAI contains 20 items to measure state anxiety and items are scored using a 4-point Likert-type scale (almost never-almost always). The shortened SAI retains 6 items (from the original 20) and has evidence supporting good internal reliability consistency and strong construct validity. Items are scored from 1 (not at all) to 4 (very much so) and added after reverse coding anxiety absent items, with higher total scores indicating higher state anxiety. The shortened SAI total score ranges from a total score of 6-24.
Time frame: baseline (0 hours) and post-intervention (24, 48 hours)
Population: Outcome measure was pre-specified to analyze data only from the Intervention-Anxiety and Control-Anxiety Arms/Groups
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention - Nausea/Vomiting | Anxiety Symptoms at Baseline 24 Hours, and 48 Hours | Baseline | 14.4 score on a scale | Standard Deviation 3.7 |
| Intervention - Nausea/Vomiting | Anxiety Symptoms at Baseline 24 Hours, and 48 Hours | 24 hours | 10.9 score on a scale | Standard Deviation 3.3 |
| Intervention - Nausea/Vomiting | Anxiety Symptoms at Baseline 24 Hours, and 48 Hours | 48 hours | 10.5 score on a scale | Standard Deviation 3.4 |
| Control - Nausea/Vomiting | Anxiety Symptoms at Baseline 24 Hours, and 48 Hours | Baseline | 15.4 score on a scale | Standard Deviation 4.1 |
| Control - Nausea/Vomiting | Anxiety Symptoms at Baseline 24 Hours, and 48 Hours | 24 hours | 13.3 score on a scale | Standard Deviation 3.5 |
| Control - Nausea/Vomiting | Anxiety Symptoms at Baseline 24 Hours, and 48 Hours | 48 hours | 12.9 score on a scale | Standard Deviation 4.1 |
p-value: 0.285Mixed Models Analysis
Primary
Chemotherapy-induced Nausea, Vomiting, and Retching (CINVR) Symptoms at Baseline, 25 Hours, and 48 Hours
CINVR involves three gastrointestinal symptoms (nausea, vomiting, retching) influenced by administration of chemotherapy. Nausea is expressed as an unpleasant feeling in the throat/epigastrium that can result in expulsion of stomach content, known as vomiting. Retching is the effort to expel stomach contents without success. The Rhodes Index of Nausea, Vomiting and Retching (INVR) was used to measure CINVR and includes 8 Likert-type items on a 5-point scale. Items are scored from 0 (least amount of distress) to 4 (the most distress) and added after reverse coding items 1,3,6, and 7 to calculate an overall INVR score. The overall score ranges from 0 to 32, with higher scores indicating higher symptom burden. Subscales for symptom experience, occurrence, and distress for each symptom (nausea, vomiting, retching) are calculated by adding corresponding scale items for each subscale. The ranges for each subscale were as follows: nausea experience (0-12), vomiting experience (0-12),
Time frame: baseline (0 hours) and post-intervention (24, 48 hours)
Population: Outcome measure was pre-specified to analyze data only from the Intervention-Nausea/Vomiting and Control-Nausea/Vomiting Arms
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention - Nausea/Vomiting | Chemotherapy-induced Nausea, Vomiting, and Retching (CINVR) Symptoms at Baseline, 25 Hours, and 48 Hours | Baseline | 9.6 score on a scale | Standard Deviation 4.6 |
| Intervention - Nausea/Vomiting | Chemotherapy-induced Nausea, Vomiting, and Retching (CINVR) Symptoms at Baseline, 25 Hours, and 48 Hours | 24 hours | 5.2 score on a scale | Standard Deviation 3.1 |
| Intervention - Nausea/Vomiting | Chemotherapy-induced Nausea, Vomiting, and Retching (CINVR) Symptoms at Baseline, 25 Hours, and 48 Hours | 48 hours | 3.9 score on a scale | Standard Deviation 3.5 |
| Control - Nausea/Vomiting | Chemotherapy-induced Nausea, Vomiting, and Retching (CINVR) Symptoms at Baseline, 25 Hours, and 48 Hours | Baseline | 8.5 score on a scale | Standard Deviation 4.4 |
| Control - Nausea/Vomiting | Chemotherapy-induced Nausea, Vomiting, and Retching (CINVR) Symptoms at Baseline, 25 Hours, and 48 Hours | 24 hours | 4.9 score on a scale | Standard Deviation 3.5 |
| Control - Nausea/Vomiting | Chemotherapy-induced Nausea, Vomiting, and Retching (CINVR) Symptoms at Baseline, 25 Hours, and 48 Hours | 48 hours | 4.4 score on a scale | Standard Deviation 4.4 |
p-value: 0.462Mixed Models Analysis
Secondary
Inpatient Fall Events at Baseline and During Intervention
Fall numbers using total number of falls reported to the National Database of Nurse Quality Indicators. Data were extracted from the bone marrow transplant and hematology/oncology units for baseline (December 2020-March 2022) and intervention (March 2022-June 2023) timeframes.
Time frame: baseline (December 2020-February 2022) and during intervention (March 2022-June 2023)
Population: Data were pre-specified to be analyzed across participating hospital units, rather than study arms.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intervention - Nausea/Vomiting | Inpatient Fall Events at Baseline and During Intervention | Baseline | 32 Fall Events |
| Intervention - Nausea/Vomiting | Inpatient Fall Events at Baseline and During Intervention | Post | 31 Fall Events |
Secondary
Medications Administered for Nausea/Vomiting Indication for 48 Hour Study Timeframe
Medications administered for nausea/vomiting indication (scopolamine, lorazepam, promethazine, prochlorperazine, olanzapine, dexamethasone, Marinol, ondansetron). Medications administered for nausea/vomiting symptom indication were extracted from the electronic medical record for participants in the nausea/vomiting symptom group.
Time frame: 48 hour intervention timeframe
Population: Outcome measure was pre-specified to collect data only from the Intervention-Nausea/Vomiting and Control-Nausea/Vomiting Arms/Groups
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention - Nausea/Vomiting | Medications Administered for Nausea/Vomiting Indication for 48 Hour Study Timeframe | 10.0 Medications Administered | Standard Deviation 5 |
| Control - Nausea/Vomiting | Medications Administered for Nausea/Vomiting Indication for 48 Hour Study Timeframe | 7.1 Medications Administered | Standard Deviation 5.3 |
p-value: 0.091t-test, 2 sided
Secondary
Patient Satisfaction at 48 Hours
An investigator-developed questionnaire was administered at the 48-hour study completion to evaluate patient satisfaction. Participants rated their satisfaction with the intervention on a 1-10 rating scale, with 10 being extremely satisfied (e.g., higher score means higher satisfaction).
Time frame: post-intervention (48 hours)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention - Nausea/Vomiting | Patient Satisfaction at 48 Hours | Rating = 1 | 0 Participants |
| Intervention - Nausea/Vomiting | Patient Satisfaction at 48 Hours | Rating = 2 | 0 Participants |
| Intervention - Nausea/Vomiting | Patient Satisfaction at 48 Hours | Rating = 3 | 0 Participants |
| Intervention - Nausea/Vomiting | Patient Satisfaction at 48 Hours | Rating = 4 | 0 Participants |
| Intervention - Nausea/Vomiting | Patient Satisfaction at 48 Hours | Rating = 5 | 0 Participants |
| Intervention - Nausea/Vomiting | Patient Satisfaction at 48 Hours | Rating = 6 | 1 Participants |
| Intervention - Nausea/Vomiting | Patient Satisfaction at 48 Hours | Rating = 7 | 2 Participants |
| Intervention - Nausea/Vomiting | Patient Satisfaction at 48 Hours | Rating = 8 | 5 Participants |
| Intervention - Nausea/Vomiting | Patient Satisfaction at 48 Hours | Rating = 9 | 8 Participants |
| Intervention - Nausea/Vomiting | Patient Satisfaction at 48 Hours | Rating =10 | 5 Participants |
| Control - Nausea/Vomiting | Patient Satisfaction at 48 Hours | Rating = 3 | 0 Participants |
| Control - Nausea/Vomiting | Patient Satisfaction at 48 Hours | Rating = 9 | 2 Participants |
| Control - Nausea/Vomiting | Patient Satisfaction at 48 Hours | Rating = 4 | 0 Participants |
| Control - Nausea/Vomiting | Patient Satisfaction at 48 Hours | Rating = 5 | 2 Participants |
| Control - Nausea/Vomiting | Patient Satisfaction at 48 Hours | Rating = 6 | 1 Participants |
| Control - Nausea/Vomiting | Patient Satisfaction at 48 Hours | Rating = 7 | 0 Participants |
| Control - Nausea/Vomiting | Patient Satisfaction at 48 Hours | Rating =10 | 7 Participants |
| Control - Nausea/Vomiting | Patient Satisfaction at 48 Hours | Rating = 8 | 3 Participants |
| Control - Nausea/Vomiting | Patient Satisfaction at 48 Hours | Rating = 1 | 0 Participants |
| Control - Nausea/Vomiting | Patient Satisfaction at 48 Hours | Rating = 2 | 0 Participants |
| Control - Nausea/Vomiting | Patient Satisfaction at 48 Hours | Rating = 8 | 5 Participants |
| Control - Nausea/Vomiting | Patient Satisfaction at 48 Hours | Rating = 7 | 3 Participants |
| Control - Nausea/Vomiting | Patient Satisfaction at 48 Hours | Rating =10 | 2 Participants |
| Control - Nausea/Vomiting | Patient Satisfaction at 48 Hours | Rating = 1 | 0 Participants |
| Control - Nausea/Vomiting | Patient Satisfaction at 48 Hours | Rating = 4 | 1 Participants |
| Control - Nausea/Vomiting | Patient Satisfaction at 48 Hours | Rating = 6 | 3 Participants |
| Control - Nausea/Vomiting | Patient Satisfaction at 48 Hours | Rating = 9 | 1 Participants |
| Control - Nausea/Vomiting | Patient Satisfaction at 48 Hours | Rating = 2 | 1 Participants |
| Control - Nausea/Vomiting | Patient Satisfaction at 48 Hours | Rating = 5 | 2 Participants |
| Control - Nausea/Vomiting | Patient Satisfaction at 48 Hours | Rating = 3 | 2 Participants |
| Control - Anxiety | Patient Satisfaction at 48 Hours | Rating = 5 | 1 Participants |
| Control - Anxiety | Patient Satisfaction at 48 Hours | Rating = 8 | 2 Participants |
| Control - Anxiety | Patient Satisfaction at 48 Hours | Rating = 6 | 5 Participants |
| Control - Anxiety | Patient Satisfaction at 48 Hours | Rating =10 | 6 Participants |
| Control - Anxiety | Patient Satisfaction at 48 Hours | Rating = 7 | 0 Participants |
| Control - Anxiety | Patient Satisfaction at 48 Hours | Rating = 2 | 0 Participants |
| Control - Anxiety | Patient Satisfaction at 48 Hours | Rating = 3 | 0 Participants |
| Control - Anxiety | Patient Satisfaction at 48 Hours | Rating = 4 | 0 Participants |
| Control - Anxiety | Patient Satisfaction at 48 Hours | Rating = 1 | 0 Participants |
| Control - Anxiety | Patient Satisfaction at 48 Hours | Rating = 9 | 4 Participants |