- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06077175
HAND MASSAGE AFTER ACUTE CORONARY SYNDROME
February 27, 2025 updated by: Özlem Ceyhan, TC Erciyes University
EFFECT of HAND MASSAGE on PATIENTS AFTER ACUTE CORONARY SYNDROME on the COMFORT and ANXIETY LEVEL
Patients suffering from Acute coronary syndrome may be hospitalized again in a shorter time than expected, and after being discharged, they may live within the limitations imposed by the disease until the end of their lives.
This situation causes anxiety in individuals.
Today, various methods are used to reduce high levels of anxiety.
Massage is the planned and purposeful application of touch and is the most common, most important and oldest complementary treatment used in traditional practices.
It is also thought that the comfort levels of individuals experiencing ACS will increase by reducing their anxiety.
This study was planned to determine the effect of hand massage applied to patients with ACS on comfort, anxiety level and vital signs.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Kayseri, Turkey
- Erciyes University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Patients experiencing Acute Coronary Syndrome for the first time,
- Anxiety score of 16 and above (moderate and severe anxiety)
- 18 years and above,
- No psychiatric disease,
- Patients who do not have communication problems and are competent to answer all questions,
Exclusion Criteria:
- Patients with uncontrolled Diabetes mellitus
- Patients who cannot communicate and have confusion,
- Those who have any limb, vascular problem or wound that prevents hand massage,
- Thrombophlebitis, occlusive arterial disease, fever etc. Those for whom massage therapy is inconvenient due to illness,
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Control group
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Experimental: intervention group
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Each individual will receive a 10-minute hand massage, 5 minutes for each hand.
Since the speed and number of repetitions of the massage movements should be at normal frequency, the massage will be performed at a speed that does not disturb the individual, is not stimulating and has a calming effect, and will not tire the practitioner.
In the massage, effleurage (stroking) and friction (circular rubbing) movements will be used, which have a circulation-supporting and tissue-relaxing effect.
Evaluations will be made within 30 minutes after the hand massage.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Beck Anxiety Scale
Time Frame: It will be applied on the 4th day at the end of the application.
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It is a self-rating scale used to determine the frequency of anxiety symptoms experienced by individuals.
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It will be applied on the 4th day at the end of the application.
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Beck Anxiety Scale
Time Frame: It will be done before the massage application, 24 hours after arrival in the intensive care unit.
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It is a self-rating scale used to determine the frequency of anxiety symptoms experienced by individuals.
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It will be done before the massage application, 24 hours after arrival in the intensive care unit.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
General Comfort Scale
Time Frame: It will be applied on the 4th day at the end of the application.
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It is used to determine the comfort level of patients.
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It will be applied on the 4th day at the end of the application.
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General Comfort Scale
Time Frame: It will be done before the massage application, 24 hours after arrival in the intensive care unit.
|
It is used to determine the comfort level of patients.
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It will be done before the massage application, 24 hours after arrival in the intensive care unit.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Cavdar AU, Yilmaz E, Baydur H. The Effect of Hand Massage Before Cataract Surgery on Patient Anxiety and Comfort: A Randomized Controlled Study. J Perianesth Nurs. 2020 Feb;35(1):54-59. doi: 10.1016/j.jopan.2019.06.012. Epub 2019 Sep 21.
- Kunikata H, Watanabe K, Miyoshi M, Tanioka T. The effects measurement of hand massage by the autonomic activity and psychological indicators. J Med Invest. 2012;59(1-2):206-12. doi: 10.2152/jmi.59.206.
- Mei L, Miao X, Chen H, Huang X, Zheng G. Effectiveness of Chinese Hand Massage on Anxiety Among Patients Awaiting Coronary Angiography: A Randomized Controlled Trial. J Cardiovasc Nurs. 2017 Mar/Apr;32(2):196-203. doi: 10.1097/JCN.0000000000000309.
- Alimohammad HS, Ghasemi Z, Shahriar S, Morteza S, Arsalan K. Effect of hand and foot surface stroke massage on anxiety and vital signs in patients with acute coronary syndrome: A randomized clinical trial. Complement Ther Clin Pract. 2018 May;31:126-131. doi: 10.1016/j.ctcp.2018.01.012. Epub 2018 Feb 13.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 30, 2023
Primary Completion (Actual)
March 1, 2024
Study Completion (Actual)
June 1, 2024
Study Registration Dates
First Submitted
October 5, 2023
First Submitted That Met QC Criteria
October 5, 2023
First Posted (Actual)
October 11, 2023
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 27, 2025
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AKSHAND
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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