Effect on Pain and Comfort Associated With Fistula Puncture

Hemodialysis Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05574595
• Other study ID #: 2022/4
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 15, 2022
• Est. completion date: November 15, 2022

Study information

• Verified date: October 2022
• Source: Kirklareli University
• Contact: Aylin AYDIN SAYILAN, PhD
• Phone: +902882145547
• Email: aylin.sayilan[@]klu.du.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: November 15, 2022
• Est. primary completion date: October 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fistula
• Hemodialysis Patients

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kirklareli University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Efficacy of Music on Pain Level	Visual Analog Scale	7 days
Secondary	The Efficacy of Music on Comfort Level	Comfort Scale	7 days