The Effect of Complementary Medicine (CAM) Treatments on Common Symptoms 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.

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Key information

Conditions

Pain Anxiety Anxiety Disorders Mental Disorders Nausea Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bnai Zion Medical Center

Haifa, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients aged 18 years
Undergoing Laparoscopic Cholecysyectomy (LC)

Exclusion criteria

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

Treatment and study plan

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.

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.

Primary outcomes

Perioperative Anxiety Expressed in Visual Analogue Scale for Anxiety (VAS-A) From 0 (Asymptomatic: no Anxiety) to 10 Extremely Symptomatic Anxiety

Time frame: 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

Sponsors and collaborators

Lead sponsor

Bnai Zion Medical Center

Other Gov

Registry information

Official study title

Patient Reported Outcomes Following Complementary Medicine Treatments in Hospitalized Patients

Important dates

Study start: 2010
Primary completion: 2020
Study completion: 2020
First posted: Nov 27, 2012
Registry last updated: May 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed