Using a Stress Ball With Music During Colonoscopy

NCT07590869 | Completed

• 1 other identifier: muhammed gönültaş
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Pain; Colonoscopy

Keywords

Anxiety; Colonoscopy; Music; Pain; Stress Ball

Outcome Measures

Primary Outcomes (3)

• Visual Analog Scale (VAS)

  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.

  15 minutes before colonoscopy

• State-Trait Anxiety Scale (STAI-S)

  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.

  15 minutes before colonoscopy

• Perception of Colonoscopy Procedure

  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.

  15 minutes before colonoscopy

Secondary Outcomes (3)

• 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

Study Arms (2)

experimental group

EXPERIMENTAL

Patients in the experimental group were given stress balls while listening to music

Other: Music and Stress Ball Intervention

control group

NO INTERVENTION

Patients in the control group were not given stress balls accompanied by music

Interventions

Music and Stress Ball Intervention OTHER

Participants in the intervention group listened to relaxing music and used a stress ball during the colonoscopy procedure. The intervention started approximately 10 minutes before the procedure and continued throughout the procedure. Patients were instructed to squeeze and release the stress ball rhythmically while focusing on the music. The music was played in the procedure room at a comfortable volume level. This combined non-pharmacological intervention aimed to divert attention, promote relaxation, and reduce pain and anxiety during colonoscopy.

experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Malatya Training and Research Hospital

Malatya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: May 15, 2026
• Study Start: August 15, 2024
• Primary Completion: January 8, 2025
• Study Completion: March 20, 2025
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)