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Massage Technique for Pain, Anxiety and Delirium in SAH Patients

Primary Purpose

Subarachnoid Hemorrhage, Anxiety, Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Massage
Sponsored by
Sara E. Hocker, M.D
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subarachnoid Hemorrhage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of aneurysmal subarachnoid hemorrhage

Exclusion Criteria:

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

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Massage technique

No intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Pain Score
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

Sleep quantity

Full Information

First Posted
October 16, 2013
Last Updated
February 21, 2018
Sponsor
Sara E. Hocker, M.D
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1. Study Identification

Unique Protocol Identification Number
NCT01982656
Brief Title
Massage Technique for Pain, Anxiety and Delirium in SAH Patients
Official Title
Effects of Massage Technique for Pain, Anxiety, and Delirium Management in ICU Patients With Subarachnoid Hemorrhage
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
February 22, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sara E. Hocker, M.D

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subarachnoid Hemorrhage, Anxiety, Pain, Delirium, Sleep

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Massage technique
Arm Type
Experimental
Arm Description
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.
Arm Title
No intervention
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Massage
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Pain Score
Description
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.
Time Frame
Baseline to 14 days
Secondary Outcome Measure Information:
Title
Sleep quantity
Time Frame
5-14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of aneurysmal subarachnoid hemorrhage Exclusion Criteria: Upper extremity deep vein thrombus Active alcohol or drug withdrawal
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Hocker, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22828950
Citation
Zolfaghari M, Eybpoosh S, Hazrati M. Effects of therapeutic touch on anxiety, vital signs, and cardiac dysrhythmia in a sample of Iranian women undergoing cardiac catheterization: a quasi-experimental study. J Holist Nurs. 2012 Dec;30(4):225-34. doi: 10.1177/0898010112453325. Epub 2012 Jul 24.
Results Reference
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PubMed Identifier
22828022
Citation
Valiee S, Bassampour SS, Nasrabadi AN, Pouresmaeil Z, Mehran A. Effect of acupressure on preoperative anxiety: a clinical trial. J Perianesth Nurs. 2012 Aug;27(4):259-66. doi: 10.1016/j.jopan.2012.05.003.
Results Reference
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PubMed Identifier
20347836
Citation
Bauer BA, Cutshall SM, Wentworth LJ, Engen D, Messner PK, Wood CM, Brekke KM, Kelly RF, Sundt TM 3rd. Effect of massage therapy on pain, anxiety, and tension after cardiac surgery: a randomized study. Complement Ther Clin Pract. 2010 May;16(2):70-5. doi: 10.1016/j.ctcp.2009.06.012. Epub 2009 Jul 14.
Results Reference
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Massage Technique for Pain, Anxiety and Delirium in SAH Patients

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