Acupressure in Hospitalized Patients

• Sponsor: Stony Brook University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02762435
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 3
• Duration (Months): 10.1
• Patients Per Site Per Month: 19.9

Study Details

Study Description

Brief Summary

After written informed consent eligible hospitalized patients will be randomized to one of 3 arms (1:1:1:): control, sham, accupressure (3 points on the hand and wrist three times per day). Quality of recovery and other measures of patient satisfaction will be recorded.

Condition or Disease	Intervention/Treatment	Phase
Acupressure	Other: sham; Other: control; Other: acupressure	N/A

Detailed Description

After written informed consent eligible hospitalized patients will be randomized to one of 3 arms (1:1:1:): control (no touch), sham (light touch), acupressure (2 minutes moderate pressure each at PC6, LI4, and HT7 three times per day). Quality of recovery using the validated Quality of Recovery (QOR) 15 score and other measures of patient satisfaction (nausea score, pain score) will be recorded at baseline and after their 6 study sessions.

Study Design

• Study Type: Interventional
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Randomized Controlled Trial of Acupressure to Improve Patient Satisfaction and Quality of Recovery in Hospitalized Patients
• Study Start Date: Mar 1, 2016
• Actual Primary Completion Date: Dec 1, 2016
• Actual Study Completion Date: Jan 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: control No pressure applied to the 3 points	Other: control; no contact with the subject
Sham Comparator: sham Light touch applied to the 3 points (2 minutes each at PC6, LI4, and HT7, three times per day for 2 days)	Other: sham; light touch at established points on hand and wrist
Experimental: acupressure Moderate pressure applied to the 3 points (2 minutes each at PC6, LI4, and HT7, three times per day for 2 days)	Other: acupressure; moderate pressure at established points on hand and wrist

Outcome Measures

Primary Outcome Measures

1. Change in Quality of Recovery score [Time Frame: Day 0, Day 2]

   The validated QOR15 score will be assessed at baseline (Day 0) and after the 6 sessions have been completed (Day 2) and the change in QOR15 (Day 2 minus Day 0) will be calculated.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. adults

2. patients at Stony Brook hospital

3. expected to be hospitalized for at least 3 days

4. able to sign informed consent and participate in the study

Exclusion Criteria:

1. Under 18 years of age

2. Do not have access to the 3 points on the hand and wrist due to skin breakdown, ulcers, cellulitis, broken bone, indwelling catheter within 5 cm radius of the pressure points.

3. Significant dementia or altered mental status that would prevent assessment of the QOR survey

4. Allergic reaction to ink

5. Stroke or other neurologic condition which precludes sensation in both upper extremities.

6. Ongoing use of regional anesthetic technique

7. Pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stony Brook Medicine	Stony Brook	New York	United States	11794-8480

Sponsors and Collaborators

• Stony Brook University

Investigators

• Principal Investigator: Elliott Bennett-Guerrero, MD, Stony Brook Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stony Brook University
• ClinicalTrials.gov Identifier: NCT02762435
• Other Study ID Numbers: 867005-3
• First Posted: May 5, 2016
• Last Update Posted: Apr 25, 2017
• Last Verified: Apr 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No

Study Results

No Results Posted as of Apr 25, 2017