Anxiety, Nausea, Pain
Conditions
Keywords
complementary medicine, hospitalized
Brief summary
This is a randomized, single blinded, interventional trial conducted in patients undergoing elective laparoscopic cholecystectomy, comparing the following three groups: Controls receiving standard-of-care (SoC) only (Group 1); intervention group receiving reflexology and SoC (Group 2); and a group receiving sham reflexology and SoC (Group 3). In all groups, level of preoperative anxiety was evaluated at entry and exit from the Holding Room Area (HRA). The evaluation was carried out using the Visual Analogue Scale for Anxiety (VAS-A) questionnaire.
Interventions
OTHERReflexology
Reflexology intervention involved a 15-minute treatment in the induction room, provided by three reflexologists from the hospital staff. The reflexology protocol was developed through a Delphi method.
OTHERSham reflexology
Sham reflexology intervention were given by two complementary medicine practitioners with knowledge in touch therapy (shiatsu) and included 15 minutes of gentle, nonspecific foot massage. Similarly to the true reflexology protocol, the protocol for this treatment was also determined in a consensus-reaching process among a group of four experienced reflexologists.
Sponsors
Bnai Zion Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients aged 18 years 2. Undergoing Laparoscopic Cholecysyectomy (LC)
Exclusion criteria
1. Patients with a history of obstructive sleep apnea 2. Contraindication for benzodiazepines 3. Hemodynamic instability 4. Leg ulcers 5. Patients undergoing a LC together with another surgical procedure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative Anxiety Expressed in Visual Analogue Scale for Anxiety (VAS-A) From 0 (Asymptomatic: no Anxiety) to 10 Extremely Symptomatic Anxiety | Baseline and 4 hours post treatment: calculated as value at 4 hours post treatment minus value at baseline | Change of VAS-A between baseline and 4 hours post-treatment |
Countries
Israel
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Reflexology Symptomatic hospitalized people randomized to reflexology on top of standard of care
Reflexology: Reflexology intervention involved a 15-minute treatment in the induction room, provided by three reflexologists from the hospital staff. The reflexology protocol was developed through a Delphi method. | 101 |
| Standard of Care Only Symptomatic hospitalized people randomized to standard of care only | 100 |
| Sham Reflexology Symptomatic hospitalized people randomized to sham reflexology on top of standard of care
Sham reflexology: Sham reflexology intervention were given by two complementary medicine practitioners with knowledge in touch therapy (shiatsu) and included 15 minutes of gentle, nonspecific foot massage. Similarly to the true reflexology protocol, the protocol for this treatment was also determined in a consensus-reaching process among a group of four experienced reflexologists. | 99 |
| Total | 300 |
Baseline characteristics
| Characteristic | Standard of Care Only | Sham Reflexology | Total | Reflexology |
|---|---|---|---|---|
| Age, Continuous | 48.5 years STANDARD_DEVIATION 15.3 | 49.9 years STANDARD_DEVIATION 16.9 | 49.8 years STANDARD_DEVIATION 15.6 | 51.2 years STANDARD_DEVIATION 14.5 |
| Number (percentage) of patients who received Anxiolytics: Diazepam or Oxazepam | 25 Participants | 24 Participants | 72 Participants | 23 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants | — |
| Sex: Female, Male Female | 66 Participants | 63 Participants | 189 Participants | 60 Participants |
| Sex: Female, Male Male | 34 Participants | 36 Participants | 111 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 101 | 0 / 100 | 0 / 99 |
| other Total, other adverse events | 0 / 101 | 0 / 100 | 0 / 99 |
| serious Total, serious adverse events | 0 / 101 | 0 / 100 | 0 / 99 |
Outcome results
Primary
Perioperative Anxiety Expressed in Visual Analogue Scale for Anxiety (VAS-A) From 0 (Asymptomatic: no Anxiety) to 10 Extremely Symptomatic Anxiety
Change of VAS-A between baseline and 4 hours post-treatment
Time frame: Baseline and 4 hours post treatment: calculated as value at 4 hours post treatment minus value at baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reflexology | Perioperative Anxiety Expressed in Visual Analogue Scale for Anxiety (VAS-A) From 0 (Asymptomatic: no Anxiety) to 10 Extremely Symptomatic Anxiety | -2.83 units on VAS-A scale | Standard Deviation 2.12 |
| Standard of Care Only | Perioperative Anxiety Expressed in Visual Analogue Scale for Anxiety (VAS-A) From 0 (Asymptomatic: no Anxiety) to 10 Extremely Symptomatic Anxiety | 0.24 units on VAS-A scale | Standard Deviation 1.06 |
| Sham Reflexology | Perioperative Anxiety Expressed in Visual Analogue Scale for Anxiety (VAS-A) From 0 (Asymptomatic: no Anxiety) to 10 Extremely Symptomatic Anxiety | -1.99 units on VAS-A scale | Standard Deviation 1.85 |