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Completed

NCT Number: NCT07590869

Using a Stress Ball With Music During Colonoscopy

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.

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Key information

Conditions

Anxiety Anxiety Disorders Colonoscopy Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Malatya Training and Research Hospital

Malatya, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  1. Visual Analog Scale (VAS)

    Time frame: 5 minutes after the colonoscopy

    Pain intensity was measured using the Visual Analog Scale (VAS). The scale ranges from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.

  2. State-Trait Anxiety Scale

    Time frame: 5 minutes after the colonoscopy

    Description: Anxiety levels were assessed using the State Anxiety Scale (STAI-S), a 20-item self-report instrument measuring situational anxiety. Scores range from 20 to 80, with higher scores indicating higher levels of anxiety.

  3. Perception of Colonoscopy Procedure

    Time frame: immediately after the colonoscopy

    Perception of the colonoscopy procedure was evaluated using a structured questionnaire assessing perceived difficulty, duration, tolerability, and emotional responses before and after the procedure. Higher scores indicate more negative perceptions of the procedure.

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Registry information

Official study title

The Effect of Using a Stress Ball Accompanied by Music During a Colonoscopy on Pain, Anxiety, and Perception of the Procedure

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 15, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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