The Effect of Stress Ball And Music on Anxiety, Stress, and Pain Levels During Platelet Apheresis Donation: Randomized Controlled Trial
Phase: NA
Conditions: Anxiety, Stress
Sponsor: Saglik Bilimleri Universitesi

OFFICIAL TITLE: 
Effects of Stress Ball Use and Music Listening on Anxiety, Stress, and Pain in Platelet 
Apheresis Donors: A Randomized Controlled Trial 
NCT NUMBER:- 
DOCUMENT TITLE: 
Study Protocol 
 
DOCUMENT DATE: 
January 31, 2023 
 
 
 
 
 
 
 
 
 
 
 
 
 

THE EFFECT OF STRESS BALL and MUSIC ON ANXIETY, STRESS, 
AND PAIN LEVELS DURING PLATELET APHERESIS DONATION: 
RANDOMIZED CONTROLLED TRIAL 
1. Introduction 
Platelet apheresis transfusion can be used for therapeutic or prophylactic purposes, 
primarily in oncology and hematology patients (1). Platelet apheresis donors may experience 
anxiety, stress, and pain due to the need for a wide-lumen vascular access site to ensure adequate 
blood flow, the complexity of the devices used during the procedure, and the need to keep a 
needle in the donor's arm for an average of 1 hour. There are numerous approaches, including 
pharmacological and non-pharmacological methods, to reduce these negative feelings (2). The 
use of non-pharmacological methods such as listening to music, squeezing a stress ball, 
watching a movie, using virtual reality glasses, daydreaming, and smelling lavender during 
invasive procedures has been shown to reduce anxiety, stress, and pain symptoms in individuals 
(3). 
During invasive procedures, stress balls, which are inexpensive and accessible, have 
been observed to be used as a distraction and attention-grabbing method to reduce anxiety, 
stress, and pain (4,5,5). Listening to music is another non-pharmacological method that can 
alleviate anxiety, stress, and pain during invasive procedures. Listening to music before and 
during invasive procedures has been found to reduce systolic blood pressure, heart rate, and 
anxiety levels (7,8).  
A review of the literature revealed no studies using squeeze ball therapy targeting the 
sense of touch and music listening targeting the sense of hearing to relieve anxiety, stress, and 
pain during platelet apheresis donation (PAD). In this context, this study aims to investigate the 
effects of applying a stress ball, a distraction-attention method, and listening to music, which 
targets the sense of hearing, on anxiety, stress, and pain levels in platelet apheresis donors, in 
addition to routine care. It is believed that the data obtained at the end of the study will provide 
evidence of the effect of stress balls and music listening used during platelet apheresis donation 
on anxiety, stress, and pain. 
Research Hypotheses 

H1: There is a significant difference in anxiety levels between donors who receive routine care, 
use stress balls, and listen to music during PAD. 
H2: There is a significant difference in stress levels among donors who receive routine care, 
use stress balls, and listen to music during PAD. 
H3: There is a significant difference in pain levels among donors who receive routine care, use 
stress balls, and listen to music during PAD. 
 
2. Materials And Methods 
Research Purpose and Design 
This study was a single-center, prospective, randomized controlled trial designed to 
investigate the effects of using stress balls, a distraction-attention method, and listening to 
music on anxiety, stress, and pain levels in PAD, in addition to routine care.  
Research Population, Sample  
When determining the sample size, the effect size was calculated using results similar 
to a master's thesis (9). The sample size for the study was calculated using the G-power 
(v3.1.9.7) program with “effect size = 0.30, alpha = 0.05, power = 0.85, number of groups = 3, 
and number of measurements = 2” using ANOVA: Fixed effects, omnibus, one-way. The 
specified calculation yielded a minimum sample size of 93 donors, with 31 donors per group. 
14 individuals who declined to participate, 15 who did not meet the inclusion criteria were 
excluded from the study. Taking all these losses into account, the study was completed with a 
total of 102 individuals, 34 in each study group. 
The study included participants aged ≥18 and ≤55 who could read Turkish, had no 
physical limitations preventing them from squeezing a stress ball, had no psychiatric disorders, 
vision, hearing, or perception problems, met the platelet apheresis donation criteria according 
to the institutional protocol, were first-time platelet apheresis donors, voluntarily wished to 
donate platelets by apheresis, and voluntarily agreed to participate in the study. 
Donors who withdrew from PAD, wished to leave the study, developed a reaction during 
donation, or were unable to complete the procedure due to insufficient blood flow through the 
catheter were not included in the study. 

Ensuring Randomization 
Platelet apheresis donors were randomly assigned to groups using a stress ball, music 
listening, and a random number table—a simple random sampling method—to minimize 
selection bias.  
Data Collection Tools 
Data were collected by researchers at a university hospital’s blood transfusion center 
between August 1, 2024, and August 1, 2025. Donors were asked to complete questionnaire 
forms before and after PAD, a process that took approximately 10-15 minutes. 
Donor Information Form (DIF): The researchers created the Donor Information Form, which 
contains a total of 14 questions. The form consists of two sections: socio-demographic 
characteristics and donor parameters. The first section contains questions about the donors' 
socio-demographic characteristics (age, gender, education level, occupation, family type, place 
of residence, and tobacco/alcohol use). The second section contains questions about donor 
characteristics (blood type information, previous blood donation, and degree of kinship with 
the recipient). 
Beck Anxiety Scale (BAS): Measures the frequency of anxiety symptoms experienced by the 
individual. Beck and colleagues developed it and, it is a 21-item Likert-type self-assessment 
scale (10). The Turkish validity and reliability study was conducted by Ulusoy and colleagues 
(11). The sum of the scores is evaluated as follows: 0-7: Minimal anxiety, 8-15: Mild anxiety, 
16-25: Moderate anxiety, 26-63: Severe anxiety. The total score is used in the evaluation of the 
scale, and an increase in the score indicates an increase in the level of anxiety (10).  
Distress Thermometer (DT): Roth and colleagues developed it in 1998 to measure and 
evaluate the psychosocial distress experienced by cancer patients (12). Its validity and 
reliability in Turkish were established by Özalp and colleagues (13). “0” represents no distress, 
“10” indicates the highest level of distress. The cutoff point is 4 points, and it is recommended 
that patients with a distress level of 4 points or higher should receive professional support (12). 
Visual Analog Scale (VAS): The Visual Pain Scale is a safe, valid, and easy-to-use tool for 
measuring pain repeatedly (14). Its validity and reliability in Turkish were established by Yaray 
and colleagues (15). “0” on the vertical or horizontal scale denotes no pain, while “10” signifies 
unbearable pain (14,15). 

Donor Monitoring Chart: The form prepared by the researchers was used to record vital signs 
such as temperature, heart rate, blood pressure, respiratory rate, and oxygen saturation before 
and after the procedure. 
The Approach Followed in Data Collection and Evaluation 
Pre-Implementation Phase 
Prior to commencing the research, a pre-implementation was conducted on a sample 
representing 10% of the individuals included in the sample scope. This exercise was done to 
test the clarity and usability of the scales and forms to be used as data collection tools and to 
evaluate the applicability of using a stress ball and listening to music. Based on the results of 
the pre-implementation, adjustments were made to the research content, forms, stress ball 
application, and music listening session, leading to the final form being determined. The data 
obtained in the pre-implementation phase were not included in the research. 
Implementation Phase 
The researchers informed donors who met the inclusion criteria about the study’s purpose, 
design, and method and obtained their consent using the Informed Consent Form prepared 
separately for each group. 
Stress Ball Group 
Ten minutes before PAD, DIF, BAS, DT, and VAS were completed as pre-tests during a face-
to-face interview, and vital signs were recorded on the Donor Monitoring Chart (DMC). When 
the PAD procedure began, a stress ball was placed in the palm of one hand. Donors were 
instructed to squeeze the ball as often as they wished for a total of 30 minutes during the 
procedure. Five minutes after the donation was completed, the BAS, DT, and VAS were filled 
out as final tests. Vital signs were recorded on the DMC, and the study was concluded.  
Music Listening Group 
Ten minutes before PAD, DIF, BAS, DT, and VAS were completed as pre-tests during a face-
to-face interview, and vital signs were recorded on the DMC. After the PAD began, donors 
listened to classical Turkish music modes played through the center's speaker system for 30 
minutes. Five minutes after the donation was completed, the BAS, DT, and VAS were filled 
out as a final test, vital signs were recorded, and the study was concluded. 

Control group 
Ten minutes before PAD, the DIF, BAS, DT, and VAS were completed as pre-tests during a 
face-to-face interview, and vital signs were recorded on the DMC. Donors in the control group 
underwent no intervention during platelet apheresis donation and continued their routine 
treatment and care. Five minutes after the procedure was completed, the BAS, DT, and VAS 
were filled out as post-tests. Vital signs were recorded, and the study was concluded. 
Ethical Aspects of the Study 
Local ethical committee approval (research protocol number: 2023.03.01.03) was obtained to 
conduct the study. Written permission was obtained from the center where the researcher would 
be working. The researchers' identity information and data obtained from the study were kept 
confidential. 
Statistical Analysis and Evaluation of Data 
The data obtained in the study were statistically analyzed using the SPSS  v29.0 (IBM) 
software package. Chi-square analyses were conducted for the individual characteristics of the 
participants, one-way ANOVA was used for the means of vital signs, and both one-way 
ANOVA and Kruskal-Wallis tests were performed for anxiety, stress, and pain levels. We 
conducted chi-square analyses for anxiety, stress, and pain levels, one-way ANOVA and 
Kruskal-Wallis for smoking and alcohol use, t-tests for dependent groups, one-way ANOVA 
for vital signs, Kruskal-Wallis for anxiety, stress, and pain levels, t-tests for dependent groups, 
and one-way ANOVA for Beck Anxiety Scale scores. Data were evaluated at a 95% confidence 
interval and a p<0.05 statistical significance level.