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Effect on Pain and Comfort Associated With Fistula Puncture

Primary Purpose

Hemodialysis Patients

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Music theraphy
Sponsored by
Kırklareli University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hemodialysis Patients focused on measuring pain, comfort

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • be volunteering,
  • 18 years or older,
  • receiving hemodialysis treatment for at least 6 months
  • not any hearing problem.

Exclusion Criteria:

  • have hearing problem
  • not be volunteering.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    The Mean of the Hemodialysis Comfort Scale scores of the experimental and group patients

    The mean of the Hemodialysis Comfort Scale scores of the control group patients

    Arm Description

    To the Experimental Group; The information form and the short form of the comfort scale will be applied to the patient who is taken to the dialysis unit to start HD treatment.

    No procedure was performed on the patients in the control group.

    Outcomes

    Primary Outcome Measures

    The Efficacy of Music on Pain Level
    Visual Analog Scale

    Secondary Outcome Measures

    The Efficacy of Music on Comfort Level
    Comfort Scale

    Full Information

    First Posted
    October 5, 2022
    Last Updated
    October 7, 2022
    Sponsor
    Kırklareli University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05574595
    Brief Title
    Effect on Pain and Comfort Associated With Fistula Puncture
    Official Title
    The Effect of Self-selected Soothing Music on Fistula Puncture-related Pain and Comfort in Hemodialysis Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 15, 2022 (Anticipated)
    Primary Completion Date
    October 15, 2022 (Anticipated)
    Study Completion Date
    November 15, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Kırklareli 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
    Purpose This study was carried out as the design of the targeted design in terms of targeting and comfort in the patient with hemodialysis. Material and Methods: It was successfully tested both in the control team of a hospital at the point of sale in Turkey and with experience. By block randomization method to randomize. Data were collected with "Patient identification formula", "Visual Analog Scale (VAS)" and "Hemodialysis Comfort Scale". Independent sample t-test was used in the analysis of the data, analysis of variance in repeated measurements and Cohen'd was used to calculate the size.
    Detailed Description
    It is appropriate to suggest a non-pharmacological rather clinical rather than a literature-free method, al. Also, due to the fact that the duration of anesthetic effect will expire from the dialysis treatment used (Subramanian et al., 2012). Participant's care continues for inappropriate pain management. This quality standard is one of the criteria of a standard rather than a preference for a simple, reliable and inexpensive non-pharmacological choice. As far as investigators know, there are very few studies investigating the effect of a patient's choice of music on pain following insertion of a needle into a fistula in hemodialysis patients. More focused on non-pharmacological types such as pharmacological and aromatherapy. Therefore, the aim of this study was to examine the effect of the type of music chosen by hemodialysis patients on pain and comfort associated with fistula puncture.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hemodialysis Patients
    Keywords
    pain, comfort

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    The Mean of the Hemodialysis Comfort Scale scores of the experimental and group patients
    Arm Type
    Experimental
    Arm Description
    To the Experimental Group; The information form and the short form of the comfort scale will be applied to the patient who is taken to the dialysis unit to start HD treatment.
    Arm Title
    The mean of the Hemodialysis Comfort Scale scores of the control group patients
    Arm Type
    No Intervention
    Arm Description
    No procedure was performed on the patients in the control group.
    Intervention Type
    Other
    Intervention Name(s)
    Music theraphy
    Other Intervention Name(s)
    There is no other name.
    Intervention Description
    In each session, the desired type of music will be played approximately 6 minutes before the procedure (Shabandokht-Zarmi et al., 2017). After the end of the music, the cannulation process will be performed by the dialysis nurse. The level of pain experienced by the patient immediately after needle insertion into the fistula will be evaluated with VAS by a research-independent nurse working in the dialysis unit.
    Primary Outcome Measure Information:
    Title
    The Efficacy of Music on Pain Level
    Description
    Visual Analog Scale
    Time Frame
    7 days
    Secondary Outcome Measure Information:
    Title
    The Efficacy of Music on Comfort Level
    Description
    Comfort Scale
    Time Frame
    7 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: be volunteering, 18 years or older, receiving hemodialysis treatment for at least 6 months not any hearing problem. Exclusion Criteria: have hearing problem not be volunteering.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Aylin AYDIN SAYILAN, PhD
    Phone
    +902882145547
    Email
    aylin.sayilan@klu.du.tr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nurşen KULAKAÇ, pHD
    Organizational Affiliation
    Gümüşhane Universıty
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effect on Pain and Comfort Associated With Fistula Puncture

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