Anxiety, Pain, Postoperative, Postpartum Complication
Conditions
Keywords
Healing Touch
Brief summary
Pain and anxiety are the most common complications after cesarean birth, and impair the mother's ability to optimally care for herself and her newborn. It is important for health care providers to evaluate options post-operatively to maximize symptom management and quality of care for these patients, including the option of complementary therapies such as Healing Touch (HT). This study examines the effects of HT after cesarean delivers , including the differences between pain (Numeric Rating Scale) and anxiety (Numeric Rating scale) through a Randomized Control Trial study design. The total sample size for the proposed study will include 160 participants. The study will include patients' age ≥18 years. Based on their randomization, the study coordinator at each site will schedule either 1) a Healing Touch (HT) practitioner for the intervention group OR 2) a non-HT practitioner who will collect data for the control group. HT practitioner will verify consent, then ask the woman to complete baseline measurements of pain and anxiety. Levels of pain and anxiety will be reassessed post-intervention.
Detailed description
Rationale: Pain and anxiety are the most common complications after cesarean birth. Pain and anxiety can impair the mother's ability to optimally care for herself and her newborn. It is important for health care providers to evaluate options post-operatively to maximize symptom management and quality of care for these patients, including the option of complementary therapies such as Healing Touch (HT). Objectives: Primary outcomes will include the differences between the intervention and control groups' pre-/post-intervention levels of pain (Numeric Rating Scale) and anxiety (Numeric Rating scale). Secondary outcomes include the relationship between HT and demographic information of the subjects. As well, the feasibility of introducing HT as a therapy for postpartum women will be assessed. Study Type: Randomized Control Trial Study Design: The total sample size for the proposed study will include 160 participants. The study will include patients' age ≥18 years having a scheduled cesarean delivery at Inova Loudoun Hospital (ILH), Inova Fair Oaks Hospital (IFOH), Inova Alexandria Hospital (IAH), and Inova Fairfax Medical Campus (IFMC) who will be enrolled prior to their scheduled cesarean delivery. Inclusion criteria for the HT group are (1) the ability to ensure informed consent and completion of study assessments; (2) the ability to speak, read, and understand English; (3) scheduled cesarean delivery; (4) ≥18 years of age. Exclusion criteria for the HT group are (1) Non-English speaking due to the fidelity and variability of the research (2) Prisoners, (3) Isolation precautions, (4) active psychosis and impaired cognition, and (5) cesarean delivery who delivers prior to scheduled cesarean date. The study is expected to last about one year from study initiation through analysis. Study Methodology: One to two weeks prior to a scheduled cesarean delivery, a member of the research team will call and screen women for eligibility on the study. If the woman electronically completes the consent form, they will be enrolled in the study and randomized into either the intervention or control group. Based on their randomization, the study coordinator at each site will schedule either 1) a Healing Touch (HT) practitioner for the intervention group OR 2) a non-HT practitioner who will collect data for the control group, and complete demographic information from the participant's medical chart. For the intervention group, the HT practitioner will verify consent, then ask the woman to complete baseline measurements of pain and anxiety. The practitioner will administer the HT intervention. Levels of pain and anxiety will be reassessed post-intervention. For the control group: a member of the research team, will ask the woman to complete baseline measurements of pain and anxiety. The subject will then be encouraged to have 15 minutes of quiet time, with the lights dimmed. After the 15 minutes of quite time, the team member will again measure the subject's levels of pain and anxiety. Statistical Methodology: Descriptive and inferential statistical techniques will be used to determine differences between the intervention and control groups.
Interventions
BEHAVIORALHealing Touch
Healing Touch (HT), with a foundation in holistic nursing, is a gentle therapy that uses touch to promote health and well-being by balancing the human energy system. Healing Touch (HT) is a biofield therapy in which practitioners use their hands in a heart-centered and intentional way to provide energetic balance to support physical, emotional, mental and spiritual health. It is safe for all ages and works in harmony with, is complementary to, and may be integrated with standard medical care. Healing Touch is a collection of standardized, noninvasive techniques that clear, energize, and balance the human and environmental energy fields.
OTHERControl
Quiet Time (QT) session is when a subject is provided with quiet for 15 minutes
Sponsors
Inova Health Care Services
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1. the ability to ensure informed consent and completion of study assessments 2. the ability to speak, read, and understand English 3. scheduled cesarean delivery 4. ≥18 years of age
Exclusion criteria
1. Non-English speaking due to the fidelity and variability of the research 2. Prisoners 3. Isolation precautions 4. active psychosis and impaired cognition 5. cesarean delivery who delivers prior to scheduled cesarean date -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Count of Participants Who Reported HIGH PAIN After the Intervention | Immediately following intervention | Participant were asked to quantify pain using a numeric pain rating scale that range from 1 (no pain) to 10 (worst pain imaginable) Visual Analog Scale: Measures pain intensity. Higher scores indicate higher levels of pain 0-10 High pain = pain between 6-10 on the Visual Analog Scale |
| Anxiety Measures After Intervention or Control Activity | Immediately following intervention | Change in anxiety before and after Healing Touch was measured using a scale with 16 questions each with a rating of 1-5, with 1=not at all and 5=extremely. The anxiety scores range from 16 to 80. Higher scores on the scale represent higher anxiety Hospital Anxiety Scale: Measures intensity of anxiety. Higher scores indicate higher levels of anxiety 16 Items Answer options 0-14 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Healing Touch Subjects in this arm get a HT session post cesarean
Healing Touch: Healing Touch (HT), with a foundation in holistic nursing, is a gentle therapy that uses touch to promote health and well-being by balancing the human energy system. Healing Touch (HT) is a biofield therapy in which practitioners use their hands in a heart-centered and intentional way to provide energetic balance to support physical, emotional, mental and spiritual health. It is safe for all ages and works in harmony with, is complementary to, and may be integrated with standard medical care. Healing Touch is a collection of standardized, noninvasive techniques that clear, energize, and balance the human and
environmental energy fields. | 74 |
| Control Subjects in this arm get a control activity of equal duration
Control: Quiet Time (QT) session is when a subject is provided with quiet for 15 minutes | 55 |
| Total | 129 |
Baseline characteristics
| Characteristic | Control | Total | Healing Touch |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 55 Participants | 129 Participants | 74 Participants |
| Age, Continuous | 35 years | 35 years | 35 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 14 Participants | 9 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 13 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 10 Participants | 20 Participants | 10 Participants |
| Race (NIH/OMB) White | 30 Participants | 76 Participants | 46 Participants |
| Region of Enrollment United States | 55 participants | 129 participants | 74 participants |
| Sex: Female, Male Female | 55 Participants | 129 Participants | 74 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 74 | 0 / 55 |
| other Total, other adverse events | 0 / 74 | 0 / 55 |
| serious Total, serious adverse events | 0 / 74 | 0 / 55 |
Outcome results
Primary
Anxiety Measures After Intervention or Control Activity
Change in anxiety before and after Healing Touch was measured using a scale with 16 questions each with a rating of 1-5, with 1=not at all and 5=extremely. The anxiety scores range from 16 to 80. Higher scores on the scale represent higher anxiety Hospital Anxiety Scale: Measures intensity of anxiety. Higher scores indicate higher levels of anxiety 16 Items Answer options 0-14
Time frame: Immediately following intervention
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Healing Touch | Anxiety Measures After Intervention or Control Activity | 18.8 units on a scale | Standard Deviation 3.52 |
| Control | Anxiety Measures After Intervention or Control Activity | 20.4 units on a scale | Standard Deviation 6.4 |
p-value: 0.000295% CI: [-3.47, -1.09]ANCOVA
Primary
Count of Participants Who Reported HIGH PAIN After the Intervention
Participant were asked to quantify pain using a numeric pain rating scale that range from 1 (no pain) to 10 (worst pain imaginable) Visual Analog Scale: Measures pain intensity. Higher scores indicate higher levels of pain 0-10 High pain = pain between 6-10 on the Visual Analog Scale
Time frame: Immediately following intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Healing Touch | Count of Participants Who Reported HIGH PAIN After the Intervention | 2 Participants |
| Control | Count of Participants Who Reported HIGH PAIN After the Intervention | 7 Participants |
Comparison: HIGH PAIN = score over 6 on a 0-10 pain scale (higher number indicating higher pain)p-value: 0.01995% CI: [1.19, 6.93]Regression, Logistic