Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 75 of 195 for:    Hemorrhage AND SAH

Massage Technique for Pain, Anxiety and Delirium in SAH Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01982656
Recruitment Status : Completed
First Posted : November 13, 2013
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
Sara E. Hocker, M.D, Mayo Clinic

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
Subarachnoid Hemorrhage Anxiety Pain Delirium Sleep Other: Massage Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : December 2013
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : February 22, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Sleep quantity [ Time Frame: 5-14 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of aneurysmal subarachnoid hemorrhage

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01982656


Locations
Layout table for location information
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Sara E. Hocker, M.D
Investigators
Layout table for investigator information
Principal Investigator: Sara Hocker, MD Mayo Clinic

Publications:
Layout table for additonal information
Responsible Party: Sara E. Hocker, M.D, Principle Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01982656     History of Changes
Other Study ID Numbers: 13-003346
First Posted: November 13, 2013    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
Layout table for MeSH terms
Subarachnoid Hemorrhage
Hemorrhage
Intracranial Hemorrhages
Delirium
Anxiety Disorders
Mental Disorders
Pathologic Processes
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases