The Effect of Complementary Medicine (CAM) Treatments on Common Symptoms in Hospitalized Patients

Not Applicable

Completed

• Conditions: Pain; Nausea; Anxiety

• Registration Number: NCT01733771
• Lead Sponsor: Bnai Zion Medical Center

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.

Detailed Description

Symptomatic patients are referred to CAM treatments by the medical staff of the departments. Patients interested in CAM treatments may receive various CAM treatments such as reflexology, acupuncture, guided imagery and hypnosis, according to patient preference and practitioner availability. Patients are requested to grade the severity of their symptoms on a visual analogue scale (0-100) before treatment and within 3 hours following treatments. Patients who are interested in standard care alone and not interested in CAM treatments grade their symptoms similarly, and serve as a control group. Primary outcomes are symptomatic relief and secondary outcomes are correlations between belief or disbelief in CAM with the primary outcomes.

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2012-07-10
• Study First Submitted QC: 2012-11-26
• Study First Posted: 2012-11-27
• Status Verified: 2019-07
• Primary Completion: 2020-12-30
• Study Completion: 2020-12-30
• Results First Submitted: 2025-04-16
• Results First Submitted QC: 2025-05-05
• Last Update Submitted: 2025-05-05
• Results First Posted: 2025-05-20
• Last Update Posted: 2025-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Bnai Zion Medical Center; 🇮🇱 Haifa, Israel