NCT01982656

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2013

Longer than P75 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

First Submitted

Initial submission to the registry

October 16, 2013

Completed
28 days until next milestone

First Posted

Study publicly available on registry

November 13, 2013

Completed
18 days until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2018

Completed
Last Updated

February 23, 2018

Status Verified

February 1, 2018

Enrollment Period

4.1 years

First QC Date

October 16, 2013

Last Update Submit

February 21, 2018

Conditions

Subarachnoid HemorrhageAnxietyPainDeliriumSleep

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Sleep quantity

    5-14 days

Study Arms (2)

Massage technique

EXPERIMENTAL

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

No intervention

PLACEBO COMPARATOR

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

Interventions

MassageOTHER

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.

Massage techniqueNo intervention

Eligibility Criteria

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

You may qualify if:

  • Clinical diagnosis of aneurysmal subarachnoid hemorrhage

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (3)

  • 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.

    PMID: 22828950BACKGROUND

  • 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.

    PMID: 22828022BACKGROUND

  • 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.

    PMID: 20347836BACKGROUND

MeSH Terms

Conditions

Subarachnoid HemorrhageAnxiety DisordersPainDelirium

Interventions

Massage

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsMental DisordersNeurologic ManifestationsSigns and SymptomsConfusionNeurobehavioral ManifestationsNeurocognitive Disorders

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Sara Hocker, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

October 16, 2013

First Posted

November 13, 2013

Study Start

December 1, 2013

Primary Completion

December 31, 2017

Study Completion

February 22, 2018

Last Updated

February 23, 2018

Record last verified: 2018-02

Locations

US(1)