Trial Outcomes & Findings for The Effect of Complementary Medicine (CAM) Treatments on Common Symptoms in Hospitalized Patients (NCT NCT01733771)

Results Overview

Change of VAS-A between baseline and 4 hours post-treatment

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

300 participants

Primary outcome timeframe

Baseline and 4 hours post treatment: calculated as value at 4 hours post treatment minus value at baseline

Results posted on

2025-05-20

Participant Flow

Participant milestones

Participant milestones
Measure	Reflexology Symptomatic hospitalized people randomized to reflexology on top of standard of care 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.	Standard of Care Only Symptomatic hospitalized people randomized to standard of care only	Sham Reflexology Symptomatic hospitalized people randomized to sham reflexology on top of standard of care 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.
Overall Study STARTED	101	100	99
Overall Study COMPLETED	101	100	99
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Reflexology n=101 Participants Symptomatic hospitalized people randomized to reflexology on top of standard of care 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.	Standard of Care Only n=100 Participants Symptomatic hospitalized people randomized to standard of care only	Sham Reflexology n=99 Participants Symptomatic hospitalized people randomized to sham reflexology on top of standard of care 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.	Total n=300 Participants Total of all reporting groups
Age, Continuous	51.2 years STANDARD_DEVIATION 14.5 • n=101 Participants	48.5 years STANDARD_DEVIATION 15.3 • n=100 Participants	49.9 years STANDARD_DEVIATION 16.9 • n=99 Participants	49.8 years STANDARD_DEVIATION 15.6 • n=300 Participants
Sex: Female, Male Female	60 Participants n=101 Participants	66 Participants n=100 Participants	63 Participants n=99 Participants	189 Participants n=300 Participants
Sex: Female, Male Male	41 Participants n=101 Participants	34 Participants n=100 Participants	36 Participants n=99 Participants	111 Participants n=300 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Number (percentage) of patients who received Anxiolytics: Diazepam or Oxazepam	23 Participants n=101 Participants	25 Participants n=100 Participants	24 Participants n=99 Participants	72 Participants n=300 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Reflexology n=101 Participants Symptomatic hospitalized people randomized to reflexology on top of standard of care 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.	Standard of Care Only n=100 Participants Symptomatic hospitalized people randomized to standard of care only	Sham Reflexology n=99 Participants Symptomatic hospitalized people randomized to sham reflexology on top of standard of care 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.
Perioperative Anxiety Expressed in Visual Analogue Scale for Anxiety (VAS-A) From 0 (Asymptomatic: no Anxiety) to 10 Extremely Symptomatic Anxiety	-2.83 units on VAS-A scale Standard Deviation 2.12	0.24 units on VAS-A scale Standard Deviation 1.06	-1.99 units on VAS-A scale Standard Deviation 1.85

Adverse Events

Reflexology

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham Reflexology

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Samuel Attias

Bnai Zion Medical Center

Phone: +972524707304

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place