Massage Technique for Pain, Anxiety and Delirium in SAH Patients

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01982656
• Other study ID #: 13-003346
• Status: Completed
• Phase: N/A
• First received: October 16, 2013
• Last updated: February 21, 2018
• Start date: December 2013
• Est. completion date: February 22, 2018

Study information

• Verified date: February 2018
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 22, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of aneurysmal subarachnoid hemorrhage

Exclusion Criteria:

• Upper extremity deep vein thrombus

• Active alcohol or drug withdrawal

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Delirium
• Hemorrhage
• Pain
• Sleep
• Subarachnoid Hemorrhage

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Sara E. Hocker, M.D

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to 14 days
Secondary	Sleep quantity		5-14 days