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HAND MASSAGE AFTER ACUTE CORONARY SYNDROME

Primary Purpose

Acute Coronary Syndrome, Anxiety

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
hand massage group
Sponsored by
TC Erciyes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acute Coronary Syndrome focused on measuring acute coronary syndrome, anxiety, comfort, han massage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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,

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    intervention group

    Control group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Beck Anxiety Scale
    It is a self-rating scale used to determine the frequency of anxiety symptoms experienced by individuals.
    Beck Anxiety Scale
    It is a self-rating scale used to determine the frequency of anxiety symptoms experienced by individuals.

    Secondary Outcome Measures

    General Comfort Scale
    It is used to determine the comfort level of patients.
    General Comfort Scale
    It is used to determine the comfort level of patients.

    Full Information

    First Posted
    October 5, 2023
    Last Updated
    October 11, 2023
    Sponsor
    TC Erciyes University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06077175
    Brief Title
    HAND MASSAGE AFTER ACUTE CORONARY SYNDROME
    Official Title
    EFFECT OF HAND MASSAGE ON PATIENTS AFTER ACUTE CORONARY SYNDROME ON THE COMFORT AND ANXIETY LEVEL
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 30, 2023 (Anticipated)
    Primary Completion Date
    December 30, 2023 (Anticipated)
    Study Completion Date
    February 27, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    TC Erciyes University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Coronary Syndrome, Anxiety
    Keywords
    acute coronary syndrome, anxiety, comfort, han massage

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    intervention group
    Arm Type
    Experimental
    Arm Title
    Control group
    Arm Type
    No Intervention
    Intervention Type
    Other
    Intervention Name(s)
    hand massage group
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Beck Anxiety Scale
    Description
    It is a self-rating scale used to determine the frequency of anxiety symptoms experienced by individuals.
    Time Frame
    It will be done before the massage application, 24 hours after arrival in the intensive care unit.
    Title
    Beck Anxiety Scale
    Description
    It is a self-rating scale used to determine the frequency of anxiety symptoms experienced by individuals.
    Time Frame
    It will be applied on the 4th day at the end of the application.
    Secondary Outcome Measure Information:
    Title
    General Comfort Scale
    Description
    It is used to determine the comfort level of patients.
    Time Frame
    It will be done before the massage application, 24 hours after arrival in the intensive care unit.
    Title
    General Comfort Scale
    Description
    It is used to determine the comfort level of patients.
    Time Frame
    It will be applied on the 4th day at the end of the application.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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,
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    ÖZLEM CEYHAN
    Phone
    +90 352 207 6666
    Ext
    28561
    Email
    ozlemg@erciyes.edu.tr

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26646596
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    29705444
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    31551136
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    22450009
    Citation
    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.
    Results Reference
    background

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    HAND MASSAGE AFTER ACUTE CORONARY SYNDROME

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