Effect on Pain and Comfort Associated With Fistula Puncture

NCT05574595 | Unknown

• 1 other identifier: 2022/4
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hemodialysis Patients

Keywords

pain; comfort

Outcome Measures

Primary Outcomes (1)

• The Efficacy of Music on Pain Level

  Visual Analog Scale

  7 days

Secondary Outcomes (1)

• The Efficacy of Music on Comfort Level

  7 days

Study Arms (2)

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

EXPERIMENTAL

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

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

NO INTERVENTION

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

Interventions

Music theraphy OTHER

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.

Also known as: There is no other name.

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• have hearing problem
• not be volunteering.

Sponsors & Collaborators

• Kırklareli University: lead

Related Publications (1)

• Sayilan S, Sayilan AA, Kulakac N. The effect of self-selected soothing music on fistula puncture-related pain and comfort levels in hemodialysis patients: a randomized controlled, single-blind, single-center study. Int Urol Nephrol. 2025 Oct 28. doi: 10.1007/s11255-025-04877-5. Online ahead of print.

  PMID: 41148531 DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nurşen KULAKAÇ, pHD

  Gümüşhane Universıty

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aylin AYDIN SAYILAN, PhD

CONTACT

+902882145547; aylin.sayilan@klu.du.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: October 10, 2022
• Study Start: October 15, 2022
• Primary Completion: October 15, 2022
• Study Completion: November 15, 2022
• Last Updated: October 10, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share