Massage Technique for Pain, Anxiety and Delirium in SAH Patients

February 21, 2018 updated by: Sara E. Hocker, M.D

Effects of Massage Technique for Pain, Anxiety, and Delirium Management in ICU Patients With Subarachnoid Hemorrhage

This research study seeks to explore the effects of massage techniques on pain and anxiety relief among patients with subarachnoid hemorrhages in the ICU setting in comparison to subarachnoid hemorrhagic patients using standard medical therapy. In addition, our aim is to decrease the overall medication use to treat pain and anxiety, and to determine the impact of massage on sleep duration, quality, and breathing. Our goal is to improve and promote comfort during the ICU stay as well as decrease the need for narcotic medication usage.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

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

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

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:

  • Clinical diagnosis of aneurysmal subarachnoid hemorrhage

Exclusion Criteria:

  • Upper extremity deep vein thrombus
  • Active alcohol or drug withdrawal

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Massage technique
In addition to standard medical care and pharmacologic interventions, massage technique for 20 minutes for 5 to 14 days while in the ICU will be provided to help alleviate pain and anxiety in the patient.
Other: Massage
twenty minute massage intervention prior to bedtime (1900-2100), to be started after day 3 of admission for a minimum of 5 consecutive days and up to fourteen days. The massage will be conducted by an RN trained in massage technique that is not caring for the patient in a direct nursing role.
Placebo Comparator: No intervention
Patients with an aneurysmal subarachnoid hemorrhage will receive standard medical care to include pharmacologic interventions prescribed by the primary physician and nonpharmacologic interventions provided by the bedside RN such as ice or heat to address their pain and anxiety needs.
Other: Massage
twenty minute massage intervention prior to bedtime (1900-2100), to be started after day 3 of admission for a minimum of 5 consecutive days and up to fourteen days. The massage will be conducted by an RN trained in massage technique that is not caring for the patient in a direct nursing role.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain Score
Time Frame: Baseline to 14 days
Over the course of the intervention period, the primary outcome of decrease in pain will be decreased as compared to the control group. This will be measured using the Pain Scale.
Baseline to 14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Sleep quantity
Time Frame: 5-14 days
5-14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sara E. Hocker, M.D

Investigators

  • Principal Investigator: Sara Hocker, MD, Mayo Clinic

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

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

December 1, 2013

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

February 22, 2018

Study Registration Dates

First Submitted

October 16, 2013

First Submitted That Met QC Criteria

November 4, 2013

First Posted (Estimate)

November 13, 2013

Study Record Updates

Last Update Posted (Actual)

February 23, 2018

Last Update Submitted That Met QC Criteria

February 21, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-003346

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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