- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02762435
Acupressure in Hospitalized Patients
April 24, 2017 updated by: Stony Brook University
Randomized Controlled Trial of Acupressure to Improve Patient Satisfaction and Quality of Recovery in Hospitalized Patients
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Stony Brook, New York, United States, 11794-8480
- Stony Brook Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- adults
- patients at Stony Brook hospital
- expected to be hospitalized for at least 3 days
- able to sign informed consent and participate in the study
Exclusion Criteria:
- Under 18 years of age
- 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.
- Significant dementia or altered mental status that would prevent assessment of the QOR survey
- Allergic reaction to ink
- Stroke or other neurologic condition which precludes sensation in both upper extremities.
- Ongoing use of regional anesthetic technique
- Pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: control
No pressure applied to the 3 points
|
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)
|
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)
|
moderate pressure at established points on hand and wrist
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Quality of Recovery score
Time Frame: 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.
|
Time Frame: Day 0, Day 2
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Elliott Bennett-Guerrero, MD, Stony Brook Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Noll E, Shodhan S, Romeiser JL, Madariaga MC, Page C, Santangelo D, Guo X, Pryor AD, Gan TJ, Bennett-Guerrero E. Efficacy of acupressure on quality of recovery after surgery: Randomised controlled trial. Eur J Anaesthesiol. 2019 Aug;36(8):557-565. doi: 10.1097/EJA.0000000000001001.
- Noll E, Shodhan S, Madariaga MC, Page CR, Santangelo D, Guo X, Al Bizri E, Pryor AD, Romeiser J, Bennett-Guerrero E. Randomized trial of acupressure to improve patient satisfaction and quality of recovery in hospitalized patients: study protocol for a randomized controlled trial. Trials. 2017 Mar 7;18(1):110. doi: 10.1186/s13063-017-1839-1.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2016
Primary Completion (ACTUAL)
December 1, 2016
Study Completion (ACTUAL)
January 1, 2017
Study Registration Dates
First Submitted
April 14, 2016
First Submitted That Met QC Criteria
May 4, 2016
First Posted (ESTIMATE)
May 5, 2016
Study Record Updates
Last Update Posted (ACTUAL)
April 25, 2017
Last Update Submitted That Met QC Criteria
April 24, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- 867005-3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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