HealthyNCT05398146
The Effect of Three Methods Used in Reducing Pain During Dressing Change
A study testing mathematical operations, ball squeezing and listening to music in people with Healthy, run by Melike Yilmaz Akdag at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled study aims to determine the effect of listening to music (LM), ball squeezing (BS), and performing mathematical operations (MO) in reducing the pain experienced during the first dressing in children aged 8-18 with appendectomy. Read more about this study
- Who is it for?
- Ages 8 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- mathematical operations, ball squeezing and listening to music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 1 Feb 2020
- 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 8 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Consisted of the child and parent's consent to participate in the study,
- The child and parent's speaking Turkish at the level of native speaker,
- The child's being 8-18 years old and undergoing appendectomy,
- Being the body temperature of the child in the normal level (36.5-37.2⁰C),
- The child's not having intense nausea and vomiting,
- The child's not having any physical, intellectual or neurological disability that would affect his/her participation.
Who cannot join
- Having a mental or neurological disability
- Children with hearing and vision impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Listening to Music, Performing Mathematics Operations and Ball Squeezing in Reducing Pain During Dressing Change in Children With Appendectomy
This randomized controlled study aims to determine the effect of listening to music (LM), ball squeezing (BS), and performing mathematical operations (MO) in reducing the pain experienced during the first dressing in children aged 8-18 with appendectomy.
Read the detailed description
The sample of the study consisted of 120 children (LM:30, BS:30, MO:30, control:30). A minute before dressing and during dressing, the children in the LM group listened to music, the children in the SB group squeezed the ball, the children in the MO group performed mathematical operations.According to the child, parent, and nurse assessment, it was determined that the mean pain score of the children in the LM and MO groups was lower than that of the BS group and control groups (p< .05).
- Conditions
- Healthy
- Being tested
- mathematical operations, ball squeezing, listening to music, kontrol grubu
- Keywords
- pain, appendectomy, child, distraction, dressing
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mathematical operationsBehavioural
Prepared by the researchers, the form involved mathematical operations such as addition, subtraction, multiplication, and division. The difficulty level of the mathematical operations in the form was determined by age groups of children. Accordingly, mathematical operations were divided into 3 groups primary school, secondary school and high school levels.
ball squeezingBehavioural
For the children in the BS group, a softball that could fit in the palm and be easily squeezed by the child was used.
listening to musicBehavioural
Children were allowed to listen to music with headphones during dressing changes.
kontrol grubuOther
No application was made during dressing change in children. Routine dressing change of the clinic was applied.
| Study group | Role | What they receive |
|---|---|---|
| Pre-Dressing | Experimental | Information about the children and their parents who agreed to participate in the study was recorded on the 'Information Form' 5 minutes before the dressing procedure by the researcher. Receives: Behavioral: mathematical operations; Behavioral: ball squeezing; Behavioral: listening to music; Other: kontrol grubu |
| During Dressing | Experimental | The first dressing of all children included in the study after appendectomy was performed by the doctor in the clinic. No distraction method was applied to the children in the control group during dressing. The children in the LM group were dressed while listening to music. The children in the BS group continued to squeeze the ball during the dressing. The children in the MO group were asked to perform mathematical operations given by the nurse. While the dressing was in progress, the pulse and oxygen saturation levels were recorded in the information form by the nurse. At the last stage of dressing, the children were asked to mark the level of pain they experienced during dressing on the VAS, immediately after the sticking plaster was placed on the surgical area. Parents and nurses assessed the pain level of the child during dressing through the VAS. Receives: Behavioral: mathematical operations; Behavioral: ball squeezing; Behavioral: listening to music; Other: kontrol grubu |
| Post-Dressing | Experimental | When the dressing was over, the application of distraction methods was terminated. After the dressing, the child's pulse and oxygen saturation levels were recorded in the information form by the nurse. Receives: Behavioral: mathematical operations; Behavioral: ball squeezing; Behavioral: listening to music; Other: kontrol grubu |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Pain Scores pre-dressing
Visual Analog Scale (VAS) was used for determine pain level in this research. Scale got 0 to 10 points (0 (Good) to 10 (Bad)).
Measured: 60 seconds
Comparison of Pain Scores During Dressing
Visual Analog Scale (VAS) was used for determine pain level in this research. Scale got 0 to 10 points (0 (Good) to 10 (Bad)).
Measured: 60 seconds
Comparison of Pain Scores post-Dressing
Visual Analog Scale (VAS) was used for determine pain level in this research. Scale got 0 to 10 points (0 (Good) to 10 (Bad)).
Measured: 60 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start1 Jan 2019
- Primary completion1 Feb 2020
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melike Yilmaz Akdag
- Sponsor type
- University, hospital or other
- Collaborators
- Kanuni Sultan Suleyman Training and Research Hospital
- Responsible party
- Sponsor-investigator, Melike Yilmaz Akdag, Okan University
- Investigators
- birsen mutlu, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05398146
- Sponsor's protocol ID
- 2018.5.07
- Status last verified
- May 2022
- First submitted
- 25 May 2022
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Listening to Music, Performing Mathematics Operations and Ball Squeezing in Reducing Pain During Dressing Change in Children With Appendectomy
- ClinicalTrials.gov ID
- NCT05398146
- Acronym / sponsor ID
- 2018.5.07
- Conditions
- Healthy
- Keywords
- pain, appendectomy, child, distraction, dressing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Melike Yilmaz AkdagUniversity, hospital or other
- Collaborators
- Kanuni Sultan Suleyman Training and Research Hospital
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 31 May 2022 (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 randomized controlled study aims to determine the effect of listening to music (LM), ball squeezing (BS), and performing mathematical operations (MO) in reducing the pain experienced during the first dressing in children aged 8-18 with appendectomy.
Detailed description
The sample of the study consisted of 120 children (LM:30, BS:30, MO:30, control:30). A minute before dressing and during dressing, the children in the LM group listened to music, the children in the SB group squeezed the ball, the children in the MO group performed mathematical operations.According to the child, parent, and nurse assessment, it was determined that the mean pain score of the children in the LM and MO groups was lower than that of the BS group and control groups (p< .05).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pre-Dressing | Experimental | Behavioral: mathematical operations, Behavioral: ball squeezing, Behavioral: listening to music, Other: kontrol grubuInformation about the children and their parents who agreed to participate in the study was recorded on the 'Information Form' 5 minutes before the dressing procedure by the researcher. |
| During Dressing | Experimental | Behavioral: mathematical operations, Behavioral: ball squeezing, Behavioral: listening to music, Other: kontrol grubuThe first dressing of all children included in the study after appendectomy was performed by the doctor in the clinic. No distraction method was applied to the children in the control group during dressing. The children in the LM group were dressed while listening to music. The children in the BS group continued to squeeze the ball during the dressing. The children in the MO group were asked to perform mathematical operations given by the nurse. While the dressing was in progress, the pulse and oxygen saturation levels were recorded in the information form by the nurse. At the last stage of dressing, the children were asked to mark the level of pain they experienced during dressing on the VAS, immediately after the sticking plaster was placed on the surgical area. Parents and nurses assessed the pain level of the child during dressing through the VAS. |
| Post-Dressing | Experimental | Behavioral: mathematical operations, Behavioral: ball squeezing, Behavioral: listening to music, Other: kontrol grubuWhen the dressing was over, the application of distraction methods was terminated. After the dressing, the child's pulse and oxygen saturation levels were recorded in the information form by the nurse. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Consisted of the child and parent's consent to participate in the study,
- The child and parent's speaking Turkish at the level of native speaker,
- The child's being 8-18 years old and undergoing appendectomy,
- Being the body temperature of the child in the normal level (36.5-37.2⁰C),
- The child's not having intense nausea and vomiting,
Key exclusion criteria (2 listed)
- Having a mental or neurological disability
- Children with hearing and vision impairment
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 |
|---|---|---|
| mathematical operationsPrepared by the researchers, the form involved mathematical operations such as addition, subtraction, multiplication, and division. The difficulty level of the mathematical operations in the form was determined by age groups of children. Accordingly, mathematical operations were divided into 3 groups primary school, secondary school and high school levels. | Behavioural | During Dressing, Post-Dressing, Pre-Dressing |
| ball squeezingFor the children in the BS group, a softball that could fit in the palm and be easily squeezed by the child was used. | Behavioural | During Dressing, Post-Dressing, Pre-Dressing |
| listening to musicChildren were allowed to listen to music with headphones during dressing changes. | Behavioural | During Dressing, Post-Dressing, Pre-Dressing |
| kontrol grubuNo application was made during dressing change in children. Routine dressing change of the clinic was applied. | Other | During Dressing, Post-Dressing, Pre-Dressing |
Primary outcome
Comparison of Pain Scores pre-dressing
Time frame: 60 seconds
Visual Analog Scale (VAS) was used for determine pain level in this research. Scale got 0 to 10 points (0 (Good) to 10 (Bad)).
Comparison of Pain Scores During Dressing
Time frame: 60 seconds
Visual Analog Scale (VAS) was used for determine pain level in this research. Scale got 0 to 10 points (0 (Good) to 10 (Bad)).
Comparison of Pain Scores post-Dressing
Time frame: 60 seconds
Visual Analog Scale (VAS) was used for determine pain level in this research. Scale got 0 to 10 points (0 (Good) to 10 (Bad)).
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 31 May 2022.
- Individual participant dataSharing planned: No
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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.
birsen mutlu principal investigator
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mathematical operations, ball squeezing and listening to music in people with Healthy, run by Melike Yilmaz Akdag 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 6 inclusion and 2 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 31 May 2022. 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?
Comparison of Pain Scores pre-dressing (time frame: 60 seconds). 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 31 May 2022; AzTrials last refreshed its copy on 6 Nov 2026.