Stress Ball and Music to Reduce Anxiety and Pain in Platelet Apheresis
NCT ID: NCT07300618
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
102 participants
INTERVENTIONAL
2024-08-01
2025-12-01
Brief Summary
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Detailed Description
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Music Listening Group Ten minutes before the platelet apheresis procedure, participants completed the Donor Information Form, Beck Anxiety Inventory (BAI), Distress Thermometer (DT), and Visual Analogue Scale (VAS) as pre-tests through face-to-face interviews. Their vital signs were recorded on the Donor Follow-up Chart. After the platelet apheresis procedure began, instrumental music composed of Classical Turkish Music modes was played for 30 minutes through the center's speaker system. Five minutes after the donation was completed, the BAI, DT, and VAS were administered again as post-tests. Vital signs were recorded, and the study procedure was concluded.
Control Group Ten minutes before the platelet apheresis procedure, participants completed the Donor Information Form, BAI, DT, and VAS as pre-tests through face-to-face interviews. Their vital signs were recorded on the Donor Follow-up Chart. During the platelet apheresis procedure, no additional intervention was applied to the donors in the control group, and they continued to receive routine care. Five minutes after the procedure was completed, the BAI, DT, and VAS were administered again as post-tests. Vital signs were recorded, and the study was concluded.
Ethical Considerations Ethical approval for the study was obtained from the institutional ethics committee (research protocol number: 2023.03.01.03). Written permission was also obtained from the institution where the study was conducted. The identities of the researchers and the data obtained from the study were kept confidential.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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müzik resital
During the platelet apheresis donation, instrumental music was played for the participant for 30 minutes.
müzik resital
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.
aferez makinesi
The platelet apheresis procedure was performed on donors using an apheresis machine.
antikoagülan çözelti
In accordance with the operating principle of the platelet apheresis device, the anticoagulant solution ACD-A is routinely used for all donors.
stres topu
The participant was instructed to squeeze a stress ball for 30 minutes during the platelet apheresis donation.
stres topu
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.
aferez makinesi
The platelet apheresis procedure was performed on donors using an apheresis machine.
antikoagülan çözelti
In accordance with the operating principle of the platelet apheresis device, the anticoagulant solution ACD-A is routinely used for all donors.
kontrol grubu
Routine treatment and follow-up were continued, and no intervention was applied.
No interventions assigned to this group
Interventions
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müzik resital
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.
stres topu
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.
aferez makinesi
The platelet apheresis procedure was performed on donors using an apheresis machine.
antikoagülan çözelti
In accordance with the operating principle of the platelet apheresis device, the anticoagulant solution ACD-A is routinely used for all donors.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
55 Years
ALL
No
Sponsors
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Saglik Bilimleri Universitesi
OTHER
Responsible Party
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Dilek Urtekin
PhD
Principal Investigators
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Seval SA Akpınar, Seval a
Role: STUDY_DIRECTOR
namık kemal üniversitesi
Locations
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Tekirdağ Namık Kemal University
Tekirdağ, Süleymanpaşa, Turkey (Türkiye)
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form: Control Group
Document Type: Informed Consent Form: Music Resital Group
Document Type: Informed Consent Form: Stress Ball Group
Other Identifiers
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2023.03.01.03
Identifier Type: -
Identifier Source: org_study_id