The Effect of Using a Stress Ball Accompanied by Music During a Colonoscopy on Pain, Anxiety, and Perception of the Procedure
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Inonu University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Visual Analog Scale (VAS)
Study Overview
Brief Summary
This study aims to evaluate whether using a stress ball together with listening to music during a colonoscopy procedure can reduce patients' pain and anxiety and improve their overall experience of the procedure. Colonoscopy is an important method for diagnosing and preventing colorectal diseases, but it can often cause discomfort, pain, and anxiety in patients.
In this randomized controlled study, 100 patients undergoing colonoscopy without sedation are divided into two groups. One group receives the intervention, which includes listening to relaxing music and using a stress ball starting before the procedure and continuing throughout it. The other group receives standard care without any additional intervention.
Pain levels, anxiety levels, and patients' perceptions of the procedure are measured before and after the colonoscopy using validated assessment tools. Patient satisfaction with the intervention is also evaluated.
The study investigates whether simple, low-cost, and non-invasive methods such as music and stress ball use can improve patient comfort and experience during colonoscopy. The findings may help healthcare providers, especially nurses, to enhance patient-centered care practices.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients undergoing outpatient colonoscopy
- •Aged 18 years and older
- •Conscious and able to communicate
- •No hearing or communication problems
- •No psychiatric disorders
- •Scheduled for colonoscopy without sedation
- •Not using anxiolytic medication
- •Willing to participate and provide written informed consent
Exclusion Criteria
- •Hospitalized patients undergoing colonoscopy
- •Patients with upper extremity dysfunction, neuromuscular disorders, or conditions preventing effective use of a stress ball (e.g., pain, injury, infection, immobilization)
- •Patients with sensory impairments
- •Patients undergoing gastroscopy
- •Patients undergoing colonoscopy with deep sedation
- •Patients with chronic pain or anxiety disorders
- •Patients using any other complementary or alternative methods during the study
- •Incomplete questionnaire data
- •Refusal to participate
Arms & Interventions
experimental group
Patients in the experimental group were given stress balls while listening to music
Intervention: Music and Stress Ball Intervention (Other)
control group
Patients in the control group were not given stress balls accompanied by music
Outcomes
Primary Outcomes
Visual Analog Scale (VAS)
Time Frame: 15 minutes before colonoscopy
Pain intensity was assessed using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst imaginable pain." Higher scores indicate greater pain intensity.
State-Trait Anxiety Scale (STAI-S)
Time Frame: 15 minutes before colonoscopy
Anxiety levels were assessed using the State Anxiety Scale of the State-Trait Anxiety Inventory (STAI-S), a 20-item self-report instrument with scores ranging from 20 to 80. Higher scores indicate higher levels of situational anxiety.
Perception of Colonoscopy Procedure
Time Frame: 15 minutes before colonoscopy
Patients' perceptions of the colonoscopy procedure were evaluated using a structured questionnaire assessing perceived difficulty, duration, tolerability, and emotional responses before and after the procedure.
Secondary Outcomes
- Visual Analog Scale (VAS)(5 minutes after the colonoscopy)
- State-Trait Anxiety Scale(5 minutes after the colonoscopy)
- Perception of Colonoscopy Procedure(immediately after the colonoscopy)
Investigators
Muhammed Gönültaş
Nurse
Inonu University