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

Patient Reported Outcomes Following Complementary Medicine Treatments in Hospitalized Patients

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.

Study Overview

• Status: Completed
• Conditions: Pain; Nausea; Anxiety
• Intervention / Treatment: Other: Reflexology; Other: Sham reflexology

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 Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Bnai Zion Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Study Population

All hospitalized patients

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reflexology; Symptomatic hospitalized people randomized to reflexology on top of standard of care	Other: 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.
No Intervention: Standard of care only; Symptomatic hospitalized people randomized to standard of care only
Sham Comparator: Sham reflexology; Symptomatic hospitalized people randomized to sham reflexology on top of standard of care	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline and 4 hours post treatment: calculated as value at 4 hours post treatment minus value at baseline

Secondary Outcome Measures

Outcome Measure	Time Frame
correlations between expectations from CAM as measured on a likert scale (0= disbelief and 5- high belief)and primary outcomes	at baseline evaluation (time 0')

Collaborators and Investigators

• Sponsor: Bnai Zion Medical Center
• Investigators: Principal Investigator: Elad Schiff, Prof, Director, Internal Medicine B

Publications and helpful links

General Publications

• Schiff E, Attias S, Matter I, Sroka G, Nae B, Arnon Z, Samuels N, Grinberg O, Ben-Arye E. Complementary and alternative medicine interventions for perioperative symptoms: A comparative effectiveness study. Complement Ther Med. 2019 Jun;44:51-55. doi: 10.1016/j.ctim.2019.03.003. Epub 2019 Mar 21.

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): December 30, 2020
• Study Completion (Actual): December 30, 2020

Study Registration Dates

• First Submitted: July 10, 2012
• First Submitted That Met QC Criteria: November 26, 2012
• First Posted (Estimated): November 27, 2012

Study Record Updates

• Last Update Posted (Actual): May 20, 2025
• Last Update Submitted That Met QC Criteria: May 5, 2025
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: complementary medicine; hospitalized
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Nausea
• Other Study ID Numbers: BNZ-0041-09

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No