Massage Technique for Pain, Anxiety and Delirium in SAH Patients

Sponsor
Sara E. Hocker, M.D (Other)
Overall Status
Completed
CT.gov ID
NCT01982656
Collaborator
(none)
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Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Massage
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effects of Massage Technique for Pain, Anxiety, and Delirium Management in ICU Patients With Subarachnoid Hemorrhage
Study Start Date :
Dec 1, 2013
Actual Primary Completion Date :
Dec 31, 2017
Actual Study Completion Date :
Feb 22, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in Pain Score [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.

Secondary Outcome Measures

  1. Sleep quantity [5-14 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Clinical diagnosis of aneurysmal subarachnoid hemorrhage
Exclusion Criteria:
  • Upper extremity deep vein thrombus

  • Active alcohol or drug withdrawal

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

Sponsors and Collaborators

  • Sara E. Hocker, M.D

Investigators

  • Principal Investigator: Sara Hocker, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Sara E. Hocker, M.D, Principle Investigator, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01982656
Other Study ID Numbers:
  • 13-003346
First Posted:
Nov 13, 2013
Last Update Posted:
Feb 23, 2018
Last Verified:
Feb 1, 2018

Study Results

No Results Posted as of Feb 23, 2018