Subarachnoid HemorrhageNCT01982656
Massage Technique for Pain, Anxiety and Delirium in SAH Patients
A study testing Massage in people with Subarachnoid Hemorrhage and Anxiety, run by Sara E. Hocker, M.D at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subarachnoid Hemorrhage, Anxiety, Pain
- What is being tested?
- Massage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to 22 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of aneurysmal subarachnoid hemorrhage
Who cannot join
- Upper extremity deep vein thrombus
- Active alcohol or drug withdrawal
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Effects of Massage Technique for Pain, Anxiety, and Delirium Management in ICU Patients With Subarachnoid Hemorrhage
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.
- Conditions
- Subarachnoid Hemorrhage, Anxiety, Pain, Delirium, Sleep
- Being tested
- Massage
- Medical subject headings
- Subarachnoid Hemorrhage, Anxiety Disorders, Pain, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 14 days
Secondary outcomes (1)
Sleep quantity
Measured: 5-14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2013 (estimated)
- Study startDec 2013
- Primary completion31 Dec 2017
- Study completion22 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Subarachnoid HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sara E. Hocker, M.D
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sara E. Hocker, M.D, Mayo Clinic
- Investigators
- Sara Hocker, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01982656
- Sponsor's protocol ID
- 13-003346
- Status last verified
- Feb 2018
- First submitted
- 16 Oct 2013
- Last updated
- 23 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22828950Valiee 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.
PubMed 22828022Bauer 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.
PubMed 20347836
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Massage Technique for Pain, Anxiety, and Delirium Management in ICU Patients With Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT01982656
- Acronym / sponsor ID
- 13-003346
- Conditions
- Subarachnoid Hemorrhage, Anxiety, Pain, Delirium, Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sara E. Hocker, M.DUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 22 Feb 2018 (actual)
- First posted
- 13 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Massage technique | Experimental | Other: MassageIn 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. |
| No intervention | Placebo comparator | Other: MassagePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of aneurysmal subarachnoid hemorrhage
Key exclusion criteria (2 listed)
- Upper extremity deep vein thrombus
- Active alcohol or drug withdrawal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Massagetwenty 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. | Other | Massage technique, No intervention |
Primary outcome
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.
1 secondary outcome
Sleep quantity
Time frame: 5-14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2018.
- Background: PubMed 22828950Zolfaghari 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.
- Background: PubMed 22828022Valiee 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.
- Background: PubMed 20347836Bauer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Hocker, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Massage in people with Subarachnoid Hemorrhage and Anxiety, run by Sara E. Hocker, M.D at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Score (time frame: Baseline to 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01982656, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2018.