Effect on Pain and Comfort Associated With Fistula Puncture

The Effect of Self-selected Soothing Music on Fistula Puncture-related Pain and Comfort in Hemodialysis Patients

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hemodialysis Patients
• Intervention / Treatment: Other: Music theraphy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aylin AYDIN SAYILAN, PhD; Phone Number: +902882145547; Email: aylin.sayilan@klu.du.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The Mean of the Hemodialysis Comfort Scale scores of the experimental and group patients; 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.	Other: Music theraphy; 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.; Other Names: There is no other name.
No Intervention: The mean of the Hemodialysis Comfort Scale scores of the control group patients; No procedure was performed on the patients in the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Efficacy of Music on Pain Level	Visual Analog Scale	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Efficacy of Music on Comfort Level	Comfort Scale	7 days

Collaborators and Investigators

• Sponsor: Kırklareli University
• Investigators: Principal Investigator: Nurşen KULAKAÇ, pHD, Gümüşhane Universıty

Study record dates

Study Major Dates

• Study Start (Anticipated): October 15, 2022
• Primary Completion (Anticipated): October 15, 2022
• Study Completion (Anticipated): November 15, 2022

Study Registration Dates

• First Submitted: October 5, 2022
• First Submitted That Met QC Criteria: October 7, 2022
• First Posted (Actual): October 10, 2022

Study Record Updates

• Last Update Posted (Actual): October 10, 2022
• Last Update Submitted That Met QC Criteria: October 7, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: pain; comfort
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Fistula
• Other Study ID Numbers: 2022/4

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