AnxietyNCT07590869
Using a Stress Ball With Music During Colonoscopy
A study testing Music and Stress Ball Intervention in people with Anxiety and Pain, run by Inonu University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Pain, Colonoscopy
- What is being tested?
- Music and Stress Ball Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2024to 20 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Patients using any other complementary or alternative methods during the study
- Incomplete questionnaire data
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Malatya Training and Research Hospital
Malatya
About this study
Official title: The Effect of Using a Stress Ball Accompanied by Music During a Colonoscopy on Pain, Anxiety, and Perception of the Procedure
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.
Read more
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
- Being tested
- Music and Stress Ball Intervention
- Keywords
- Anxiety, Colonoscopy, Music, Pain, Stress Ball
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music and Stress Ball InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Patients in the experimental group were given stress balls while listening to music Receives: Other: Music and Stress Ball Intervention |
| control group | No intervention | Patients in the control group were not given stress balls accompanied by music |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 15 minutes before colonoscopy
Secondary outcomes (3)
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.
Measured: 5 minutes after the colonoscopy
State-Trait Anxiety Scale
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.
Measured: 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.
Measured: immediately after the colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start15 Aug 2024
- Primary completion8 Jan 2025
- Study completion20 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammed Gönültaş, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07590869
- Sponsor's protocol ID
- muhammed gönültaş
- Status last verified
- May 2026
- First submitted
- 15 Apr 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to privacy and ethical considerations.
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using a Stress Ball Accompanied by Music During a Colonoscopy on Pain, Anxiety, and Perception of the Procedure
- ClinicalTrials.gov ID
- NCT07590869
- Acronym / sponsor ID
- muhammed gönültaş
- Conditions
- Anxiety, Pain, Colonoscopy
- Keywords
- Anxiety, Colonoscopy, Music, Pain, Stress Ball
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 8 Jan 2025 (actual)
- Study completion
- 20 Mar 2025 (actual)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: Music and Stress Ball InterventionPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients undergoing outpatient colonoscopy
- Aged 18 years and older
- Conscious and able to communicate
- No hearing or communication problems
- No psychiatric disorders
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music and Stress Ball InterventionParticipants 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. | Other | experimental group |
Primary outcome
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.
3 secondary outcomes
Visual Analog Scale (VAS)
Time frame: 5 minutes after the colonoscopy
State-Trait Anxiety Scale
Time frame: 5 minutes after the colonoscopy
Perception of Colonoscopy Procedure
Time frame: immediately after the colonoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to privacy and ethical considerations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music and Stress Ball Intervention in people with Anxiety and Pain, run by Inonu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: 15 minutes before colonoscopy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.