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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental | Patients in the experimental group were given stress balls while listening to music |
|
| control group | No Intervention | Patients in the control group were not given stress balls accompanied by music |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) | 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. | 5 minutes after the colonoscopy |
| State-Trait Anxiety Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Malatya Training and Research Hospital | Malatya | Turkey (Türkiye) |
Individual participant data (IPD) will not be shared due to privacy and ethical considerations.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 18, 2023 | Apr 15, 2026 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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. |
| 5 minutes after the colonoscopy |
| Perception of Colonoscopy Procedure | 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. | immediately after the colonoscopy |