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

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