跳至主要内容
临床试验/NCT07300618
NCT07300618
已完成
不适用

The Effect of Stress Ball And Music on Anxiety, Stress, and Pain Levels During Platelet Apheresis Donation: Randomized Controlled Trial

Saglik Bilimleri Universitesi1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2024年8月1日最近更新:

概览

阶段
不适用
状态
已完成
入组人数
102
试验地点
1
主要终点
Pain Intensity Measured by the Visual Analogue Scale (VAS)

概览

简要总结

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.

详细描述

Data Collection and Evaluation Process Pre-Implementation Phase Before starting the study, a pilot test was conducted with 10% of the individuals representing the study sample to evaluate the understandability and usability of the scales and forms to be used as data collection tools, as well as to assess the feasibility of stress ball and music interventions. Based on the results of the pilot study, necessary revisions were made to the study content, forms, stress ball application, and music intervention, and the final version of the study protocol was created. Data obtained from the pilot study were not included in the main analysis. Implementation Phase Donors who met the inclusion criteria were informed by the researchers about the purpose, design, and method of the study. Written informed consent was obtained from all participants using separate Informed Consent Forms prepared for each group. Stress Ball Group Ten minutes before the platelet apheresis procedure, participants completed the Donor Information Form, Beck Anxiety Inventory (BAI), Distress Thermometer (DT), and Visual Analog Scale (VAS) as a pre-test through face-to-face interviews. Vital signs were recorded on the Donor Monitoring Chart. When the platelet apheresis procedure began, a stress ball was placed in the donor's hand. Participants were instructed to squeeze the ball at their preferred frequency for a total of 30 minutes during the apheresis procedure. Five minutes after the donation was completed, the BAI, DT, and VAS were administered again as post-tests. Vital signs were recorded on the Donor Follow-up Table, indicating that the study procedure was complete.

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

müzik resital

Experimental

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

干预措施: müzik resital (Other)

müzik resital

Experimental

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

干预措施: aferez makinesi (Device)

müzik resital

Experimental

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

干预措施: antikoagülan çözelti (Drug)

stres topu

Experimental

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

干预措施: stres topu (Other)

stres topu

Experimental

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

干预措施: aferez makinesi (Device)

stres topu

Experimental

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

干预措施: antikoagülan çözelti (Drug)

结局指标

主要结局

Pain Intensity Measured by the Visual Analogue Scale (VAS)

时间窗: 30 minutes

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.

Anxiety Levels Measured by the Beck Anxiety Inventory (BAI)

时间窗: 30 minutes

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.

Stress Levels Measured by the Distress Thermometer (DT)

时间窗: 30 minutes

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dilek Urtekin

PhD

Saglik Bilimleri Universitesi

研究点 (1)

Loading locations...

相似试验