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

NCT01733771 | Completed Results

• 1 other identifier: BNZ-0041-09
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Nausea; Anxiety

Keywords

complementary medicine; hospitalized

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Reflexology

EXPERIMENTAL

Symptomatic hospitalized people randomized to reflexology on top of standard of care

Other: Reflexology

Standard of care only

NO INTERVENTION

Symptomatic hospitalized people randomized to standard of care only

Sham reflexology

SHAM COMPARATOR

Symptomatic hospitalized people randomized to sham reflexology on top of standard of care

Other: Sham reflexology

Interventions

Reflexology OTHER

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.

Reflexology

Sham reflexology OTHER

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.

Sham reflexology

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 years
• Undergoing Laparoscopic Cholecysyectomy (LC)

You may not qualify if:

• Patients with a history of obstructive sleep apnea
• Contraindication for benzodiazepines
• Hemodynamic instability
• Leg ulcers
• Patients undergoing a LC together with another surgical procedure.

Sponsors & Collaborators

• Bnai Zion Medical Center: lead

Study Sites (1)

Bnai Zion Medical Center

Haifa, Israel

Location

Related Publications (2)

• Samuel A, Lital KB, Mostafa S, Ariel S, Yael G, Eran BA, Ibrahim M, Gideon S, Sagi G, Dan S, Elad S. Effectiveness of standard of care, vs. its combination with reflexology and sham reflexology on preoperative anxiety in patients undergoing elective laparoscopic cholecystectomy: a single-blinded randomized controlled trial. Front Med (Lausanne). 2025 Sep 12;12:1634575. doi: 10.3389/fmed.2025.1634575. eCollection 2025.

  PMID: 41020221 DERIVED

• 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.

  PMID: 31126575 DERIVED

MeSH Terms

Conditions

Pain; Nausea; Anxiety Disorders

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Mental Disorders

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Results Point of Contact

• Title: Dr. Samuel Attias
• Organization: Bnai Zion Medical Center

samuel.attias@b-zion.org.il

+972524707304

Study Officials

• Elad Schiff, Prof

  Director, Internal Medicine B

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2012
• First Posted: November 27, 2012
• Study Start: April 1, 2010
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: May 20, 2025
• Results First Posted: May 20, 2025

Record last verified: 2019-07

Locations

IL (1)