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

Bnai Zion Medical Center

Status: Completed

Conditions: Nausea; Anxiety; Pain

Treatments: Other: Reflexology; Other: Sham reflexology

Study type: Interventional

Funder types: Other

Identifiers

NCT01733771

BNZ-0041-09

Details and patient eligibility

About

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.

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 3 patient groups

Reflexology

Experimental group

Description:

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

Treatment:

Other: Reflexology

Standard of care only

No Intervention group

Description:

Symptomatic hospitalized people randomized to standard of care only

Sham reflexology

Sham Comparator group

Description:

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

Treatment:

Other: Sham reflexology