NCT02762435

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 14, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 5, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

April 25, 2017

Status Verified

April 1, 2017

Enrollment Period

9 months

First QC Date

April 14, 2016

Last Update Submit

April 24, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Quality of Recovery score

    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

Study Arms (3)

control

PLACEBO COMPARATOR

No pressure applied to the 3 points

Other: control

sham

SHAM COMPARATOR

Light touch applied to the 3 points (2 minutes each at PC6, LI4, and HT7, three times per day for 2 days)

Other: sham

acupressure

EXPERIMENTAL

Moderate pressure applied to the 3 points (2 minutes each at PC6, LI4, and HT7, three times per day for 2 days)

Other: acupressure

Interventions

shamOTHER

light touch at established points on hand and wrist

sham
controlOTHER

no contact with the subject

control

moderate pressure at established points on hand and wrist

acupressure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stony Brook Medicine

Stony Brook, New York, 11794-8480, United States

Location

Related Publications (2)

  • 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.

MeSH Terms

Interventions

salicylhydroxamic acidAcupressure

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Elliott Bennett-Guerrero, MD

    Stony Brook Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2016

First Posted

May 5, 2016

Study Start

March 1, 2016

Primary Completion

December 1, 2016

Study Completion

January 1, 2017

Last Updated

April 25, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations