Stress Ball and Music to Reduce Anxiety and Pain in Platelet Apheresis

NCT07300618 | Completed

• 1 other identifier: 2023.03.01.03
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

This study was conducted as a single-center, prospective, randomized controlled trial to investigate the effects of stress ball use-a distraction and attention-directing method-and music listening, which targets the auditory sensory pathway, on anxiety, stress, and pain levels in platelet apheresis donors beyond routine care. The study sample consisted of 102 donors aged 18 to 55 years who were donating platelets for the first time at a university hospital blood transfusion center. The participants were divided into three groups: 34 in the stress ball group, 34 in the music listening group, and 34 in the control group. Data were collected using the Donor Information Form, the Beck Anxiety Inventory (BAI), the Visual Analogue Scale (VAS) for pain, the Distress Thermometer (DT), and the Donor Follow-up Chart. During platelet apheresis, participants in the stress ball group were instructed to squeeze a stress ball for 30 minutes, those in the music group listened to instrumental music for 30 minutes, and the control group received only routine care without any additional intervention.

Conditions

Anxiety; Stress

Keywords

Platelet apheresis; Anxiety; Stress; Nursing

Outcome Measures

Primary Outcomes (3)

• Pain Intensity Measured by the Visual Analogue Scale (VAS)

  The Visual Analogue Scale (VAS) is a validated, self-reported measure used to assess pain intensity. The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain. Higher scores represent greater pain intensity. Pain will be measured immediately before and immediately after the platelet apheresis procedure.

  30 minutes

• Anxiety Levels Measured by the Beck Anxiety Inventory (BAI)

  The Beck Anxiety Inventory (BAI) is a 21-item, self-reported questionnaire used to assess the severity of anxiety symptoms. Each item is scored from 0 to 3, producing a total score ranging from 0 to 63. Higher scores indicate higher levels of anxiety. Anxiety will be measured immediately before and immediately after the platelet apheresis procedure in all groups.

  30 minutes

• Stress Levels Measured by the Distress Thermometer (DT)

  The Distress Thermometer (DT) is a validated, self-reported screening tool used to assess stress and distress levels. It consists of a single-item visual scale ranging from 0 to 10, where 0 indicates no stress/distress and 10 indicates extreme stress/distress. Higher scores represent higher levels of stress. Stress levels will be measured immediately before and immediately after the platelet apheresis procedure in all groups.

  30 minutes

Study Arms (3)

müzik resital

EXPERIMENTAL

During the platelet apheresis donation, instrumental music was played for the participant for 30 minutes.

Other: müzik resital; Device: aferez makinesi; Drug: antikoagülan çözelti

stres topu

EXPERIMENTAL

The participant was instructed to squeeze a stress ball for 30 minutes during the platelet apheresis donation.

Other: stres topu; Device: aferez makinesi; Drug: antikoagülan çözelti

kontrol grubu

NO INTERVENTION

Routine treatment and follow-up were continued, and no intervention was applied.

Interventions

müzik resital OTHER

After the platelet apheresis procedure began, donors in the music listening group were exposed to instrumental music composed of Classical Turkish Music modes for 30 minutes through the center's speaker system.

müzik resital

stres topu OTHER

When the platelet apheresis procedure began, a stress ball was placed in the palm of one hand of the donors in the stress ball group. They were instructed to squeeze the ball at their preferred frequency for a total of 30 minutes during the apheresis procedure.

stres topu

aferez makinesi DEVICE

The platelet apheresis procedure was performed on donors using an apheresis machine.

Also known as: Spektral Optik

müzik resital; stres topu

antikoagülan çözelti DRUG

In accordance with the operating principle of the platelet apheresis device, the anticoagulant solution ACD-A is routinely used for all donors.

Also known as: ACD-A

müzik resital; stres topu

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Donors who:
• Were literate in Turkish
• Had no physical limitations preventing them from squeezing a stress ball
• Had no psychiatric disorders or visual, auditory, or perceptual impairments
• Met the institution's platelet apheresis donation criteria
• Were donating platelets for the first time
• Voluntarily wished to donate platelets
• Agreed to participate in the study

You may not qualify if:

• Donors who:
• Withdrew from platelet apheresis donation
• Wished to withdraw from the study
• Developed a reaction during the donation
• Had insufficient blood flow through the catheter
• Were unable to complete the platelet apheresis donation

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Tekirdağ Namık Kemal University

Tekirdağ, Süleymanpaşa, 59100, Turkey (Türkiye)

Location

Related Publications (7)

• Wen X, Shi J, Tan W, Jiang H, Wang D, Su J, Yang G, Zhang B. Effects of aromatherapy and music therapy on patients' anxiety during MRI examinations: a randomized controlled trial. Eur Radiol. 2023 Apr;33(4):2510-2518. doi: 10.1007/s00330-022-09230-3. Epub 2022 Nov 6.

  PMID: 36335480 BACKGROUND

• Abdul Hamid MR, Mansor MB, Zainal Abidin MF. Music therapy for reducing anxiety in patients undergoing total knee replacement surgery under subarachnoid anesthesia. J Orthop Surg (Hong Kong). 2022 May-Aug;30(2):10225536221122347. doi: 10.1177/10225536221122347.

  PMID: 36031855 BACKGROUND

• Yanes AF, Weil A, Furlan KC, Poon E, Alam M. Effect of Stress Ball Use or Hand-holding on Anxiety During Skin Cancer Excision: A Randomized Clinical Trial. JAMA Dermatol. 2018 Sep 1;154(9):1045-1049. doi: 10.1001/jamadermatol.2018.1783.

  PMID: 30027283 BACKGROUND

• Duncanson E, Le Leu RK, Shanahan L, Macauley L, Bennett PN, Weichula R, McDonald S, Burke ALJ, Collins KL, Chur-Hansen A, Jesudason S. The prevalence and evidence-based management of needle fear in adults with chronic disease: A scoping review. PLoS One. 2021 Jun 10;16(6):e0253048. doi: 10.1371/journal.pone.0253048. eCollection 2021.

  PMID: 34111207 BACKGROUND

• Kabacoff RI, Segal DL, Hersen M, Van Hasselt VB. Psychometric properties and diagnostic utility of the Beck Anxiety Inventory and the State-Trait Anxiety Inventory with older adult psychiatric outpatients. J Anxiety Disord. 1997 Jan-Feb;11(1):33-47. doi: 10.1016/s0887-6185(96)00033-3.

  PMID: 9131880 BACKGROUND

• Gezginci E, Iyigun E, Kibar Y, Bedir S. Three Distraction Methods for Pain Reduction During Cystoscopy: A Randomized Controlled Trial Evaluating the Effects on Pain, Anxiety, and Satisfaction. J Endourol. 2018 Nov;32(11):1078-1084. doi: 10.1089/end.2018.0491.

  PMID: 30280915 BACKGROUND

• Cline ME, Herman J, Shaw ER, Morton RD. Standardization of the visual analogue scale. Nurs Res. 1992 Nov-Dec;41(6):378-80. No abstract available.

  PMID: 1437591 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Seval SA Akpınar, Seval a

  namık kemal üniversitesi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 24, 2025
• Study Start: August 1, 2024
• Primary Completion: November 20, 2025
• Study Completion: December 1, 2025
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)