Pain, PostoperativeNCT05882929
The Effect of Distraction in the Postoperative Period of Pediatric Patients Undergoing Outpatient Surgery
A study testing Watching Cartoons and ball spin in people with Pain, Postoperative and Surgery, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to examine the effects of distraction methods such as watching cartoons and ball squeezing on the level of pain and physiological parameters in the postoperative period in children aged 6-12 years who have outpatient surgery. The research is a randomized controlled trial. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Pain, Postoperative, Surgery, Child, Only
- What is being tested?
- Watching Cartoons and ball spin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2023to 1 Jul 2024
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 6-12 years
- Children with day surgery surgery
- Children with American Society of Anesthesiologists classification (ASA) I-II (ASA score is given in the preoperative period by the anesthesiologist)
- Parents who volunteered to participate in the study
- Turkish speaking children
Who cannot join
- Children who have had previous surgery
- Children with the American Society of Anesthesiologists classification (ASA) III
- Children with congenital anomalies, psychiatric, neurological and chronic diseases
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Selcuk University
Konya, Selcuklu, 42060
Selcuk University
About this study
Official title: The Effect of Distraction Methods on Pain Level and Physiological Parameters in the Postoperative Period of Pediatric Patients Undergoing Outpatient Surgery: A Randomized Controlled Study
The aim of the study is to examine the effects of distraction methods such as watching cartoons and ball squeezing on the level of pain and physiological parameters in the postoperative period in children aged 6-12 years who have outpatient surgery. The research is a randomized controlled trial. The sample number was determined as 40 children (total 120) in each group. Information Form, Physiological Parameters Follow-up Form, Wong-Baker Faces Pain Scale will be used to collect research data. In the initiative group, two attempts will be implemented, namely watching cartoons and squeezing the ball. Interventions will be implemented for a total of 15 minutes. Physiological Parameters Follow-up Form and Wong-Baker Faces Pain Scale will be filled in before the interventions are applied, 10 minutes during the intervention and 5 minutes after the intervention is completed. In the control group, the 10th and 20th minute physiological parameters and the Wong-Baker Faces Pain Scale will be evaluated after the child comes to the service after the operation and is prepared for the postoperative period (taking vital signs, putting on clothes, controlling bleeding, telling the feeding time, etc.). In the analysis of study data; chi-square test for descriptive statistics, chi-square test for repeated measurements, single factor analysis of variance, Mann-Whitney U test and Friedman will be used. In the study, values at the p<0.05 level were considered statistically significant.
Read the detailed description
The aim of the study is to examine the effects of distraction methods such as watching cartoons and ball squeezing on the level of pain and physiological parameters in the postoperative period in children aged 6-12 years who have outpatient surgery. The research is a randomized controlled trial. The sample number was determined as 40 children (total 120) in each group. Information Form, Physiological Parameters Follow-up Form, Wong-Baker Faces Pain Scale will be used to collect research data. In the initiative group, two attempts will be implemented, namely watching cartoons and squeezing the ball. Interventions will be implemented for a total of 15 minutes. Physiological Parameters Follow-up Form and Wong-Baker Faces Pain Scale will be filled in before the interventions are applied, 10 minutes during the intervention and 5 minutes after the intervention is completed. In the control group, the 10th and 20th minute physiological parameters and the Wong-Baker Faces Pain Scale will be evaluated after the child comes to the service after the operation and is prepared for the postoperative period (taking vital signs, putting on clothes, controlling bleeding, telling the feeding time, etc.). In the analysis of study data; chi-square test for descriptive statistics, chi-square test for repeated measurements, single factor analysis of variance, Mann-Whitney U test and Friedman will be used. In the study, values at the p<0.05 level were considered statistically significant.
- Conditions
- Pain, Postoperative, Surgery, Child, Only
- Being tested
- Watching Cartoons, ball spin
- Keywords
- Pain, Surgery, Pediatric, Postoperative
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Watching CartoonsOther
The cartoon will be watched after the child comes to the service after the operation and the postoperative period is prepared (taking the vital signs, putting on the clothes, controlling the bleeding, telling the feeding time, etc.).
ball spinOther
ball squeezing will be applied after the child comes to the service after the operation and after the postoperative period preparation is made (taking the vital signs, dressing the clothes, controlling the bleeding, telling the feeding time, etc.).
| Study group | Role | What they receive |
|---|---|---|
| Experiment 1: Watching Cartoons | Experimental | Watching Cartoon Movies will be performed after the child comes to the service after the operation and prepares for the postoperative period (taking vital signs, putting on clothes, controlling bleeding, telling the feeding time, etc.). Interventions will be implemented for a total of 15 minutes. Physiological Parameters Follow-up Form and Wong-Baker Faces Pain Scale will be filled in before the interventions are applied, 10 minutes during the intervention and 5 minutes after the intervention is completed. Receives: Other: Watching Cartoons |
| Experiment 1: ball spin | Experimental | ball squeezing will be applied after the child comes to the service after the operation and the postoperative period preparation is made (taking the vital signs, putting on the clothes, controlling the bleeding, telling the feeding time, etc.). Interventions will be implemented for a total of 15 minutes. Physiological Parameters Follow-up Form and Wong-Baker Faces Pain Scale will be filled in before the interventions are applied, 10 minutes during the intervention and 5 minutes after the intervention is completed. Receives: Other: ball spin |
| Control | No intervention | In the control group, the 10th and 20th minute physiological parameters and Wong-Baker Faces Pain Scale will be evaluated after the child comes to the service after the operation and is prepared for the postoperative period (taking vital signs, putting on clothes, controlling bleeding, telling the feeding time, etc.). |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain level of children
Wong Baker Pain Faces Scale mean score Wong-Baker Pain Faces Scale is widely used with people ages three and older, not limited to children. This self-assessment tool must be understood by the patient, so they are able to choose the face that best illustrates the physical pain they are experiencing. It is a tool to be used by a third person, parents, healthcare professionals, or caregivers, to assess the patient's pain. The scale is 0-10 scale. The six illustrated faces on the cards show a range of emotions, from a smiling face (0 'no pain) to a crying face (10 "worst pain"). 0 indicates no pain, 10 indicates the most severe pain. It is measured before, at the 10th minute and after the intervention.
Measured: Just before the interventions and 5 minutes after the intervention
physiological parametres of the child: body temperature level
body temperature change
Measured: Just before the interventions and 5 minutes after the intervention
physiological parametres of the child: peak heart rate
heart rate change
Measured: Just before the interventions and 5 minutes after the intervention
physiological parametres of the child: respiratory rate
respiratory rate change
Measured: Just before the interventions and 5 minutes after the intervention
physiological parametres of the child: oxygen saturation (SpO2)
SpO2 level change
Measured: Just before the interventions and 5 minutes after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start1 Mar 2023
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Selcuk 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The research is a randomized controlled trial. In this parallel group study, there will be two intervention groups (watching cartoons and ball squeezing) and a control group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevinc Akkoyun, Selcuk University
- Investigators
- Fatma Tas Arslan, professor, Study director, Selcuk UniversityMehmet Sarıkaya, Doctor, Study chair, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05882929
- Sponsor's protocol ID
- 2021/45
- Status last verified
- Mar 2024
- First submitted
- 3 Dec 2022
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The effect of distraction methods on the postoperative period of pediatric patients undergoing outpatient surgery
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Distraction Methods on Pain Level and Physiological Parameters in the Postoperative Period of Pediatric Patients Undergoing Outpatient Surgery: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05882929
- Acronym / sponsor ID
- 2021/45
- Conditions
- Pain, Postoperative, Surgery, Child, Only
- Keywords
- Pain, Surgery, Pediatric, Postoperative
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 31 May 2023 (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.
The aim of the study is to examine the effects of distraction methods such as watching cartoons and ball squeezing on the level of pain and physiological parameters in the postoperative period in children aged 6-12 years who have outpatient surgery. The research is a randomized controlled trial. The sample number was determined as 40 children (total 120) in each group. Information Form, Physiological Parameters Follow-up Form, Wong-Baker Faces Pain Scale will be used to collect research data. In the initiative group, two attempts will be implemented, namely watching cartoons and squeezing the ball. Interventions will be implemented for a total of 15 minutes. Physiological Parameters Follow-up Form and Wong-Baker Faces Pain Scale will be filled in before the interventions are applied, 10 minutes during the intervention and 5 minutes after the intervention is completed. In the control group, the 10th and 20th minute physiological parameters and the Wong-Baker Faces Pain Scale will be evaluated after the child comes to the service after the operation and is prepared for the postoperative period (taking vital signs, putting on clothes, controlling bleeding, telling the feeding time, etc.). In the analysis of study data; chi-square test for descriptive statistics, chi-square test for repeated measurements, single factor analysis of variance, Mann-Whitney U test and Friedman will be used. In the study, values at the p<0.05 level were considered statistically significant.
Detailed description
The aim of the study is to examine the effects of distraction methods such as watching cartoons and ball squeezing on the level of pain and physiological parameters in the postoperative period in children aged 6-12 years who have outpatient surgery. The research is a randomized controlled trial. The sample number was determined as 40 children (total 120) in each group. Information Form, Physiological Parameters Follow-up Form, Wong-Baker Faces Pain Scale will be used to collect research data. In the initiative group, two attempts will be implemented, namely watching cartoons and squeezing the ball. Interventions will be implemented for a total of 15 minutes. Physiological Parameters Follow-up Form and Wong-Baker Faces Pain Scale will be filled in before the interventions are applied, 10 minutes during the intervention and 5 minutes after the intervention is completed. In the control group, the 10th and 20th minute physiological parameters and the Wong-Baker Faces Pain Scale will be evaluated after the child comes to the service after the operation and is prepared for the postoperative period (taking vital signs, putting on clothes, controlling bleeding, telling the feeding time, etc.). In the analysis of study data; chi-square test for descriptive statistics, chi-square test for repeated measurements, single factor analysis of variance, Mann-Whitney U test and Friedman will be used. In the study, values at the p<0.05 level were considered statistically significant.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- The research is a randomized controlled trial. In this parallel group study, there will be two intervention groups (watching cartoons and ball squeezing) and a control group.
| Arm | Type | Receives |
|---|---|---|
| Experiment 1: Watching Cartoons | Experimental | Other: Watching CartoonsWatching Cartoon Movies will be performed after the child comes to the service after the operation and prepares for the postoperative period (taking vital signs, putting on clothes, controlling bleeding, telling the feeding time, etc.). Interventions will be implemented for a total of 15 minutes. Physiological Parameters Follow-up Form and Wong-Baker Faces Pain Scale will be filled in before the interventions are applied, 10 minutes during the intervention and 5 minutes after the intervention is completed. |
| Experiment 1: ball spin | Experimental | Other: ball spinball squeezing will be applied after the child comes to the service after the operation and the postoperative period preparation is made (taking the vital signs, putting on the clothes, controlling the bleeding, telling the feeding time, etc.). Interventions will be implemented for a total of 15 minutes. Physiological Parameters Follow-up Form and Wong-Baker Faces Pain Scale will be filled in before the interventions are applied, 10 minutes during the intervention and 5 minutes after the intervention is completed. |
| Control | No intervention | –In the control group, the 10th and 20th minute physiological parameters and Wong-Baker Faces Pain Scale will be evaluated after the child comes to the service after the operation and is prepared for the postoperative period (taking vital signs, putting on clothes, controlling bleeding, telling the feeding time, etc.). |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged 6-12 years
- Children with day surgery surgery
- Children with American Society of Anesthesiologists classification (ASA) I-II (ASA score is given in the preoperative period by the anesthesiologist)
- Parents who volunteered to participate in the study
- Turkish speaking children
Key exclusion criteria (3 listed)
- Children who have had previous surgery
- Children with the American Society of Anesthesiologists classification (ASA) III
- Children with congenital anomalies, psychiatric, neurological and chronic diseases
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 |
|---|---|---|
| Watching CartoonsThe cartoon will be watched after the child comes to the service after the operation and the postoperative period is prepared (taking the vital signs, putting on the clothes, controlling the bleeding, telling the feeding time, etc.). | Other | Experiment 1: Watching Cartoons |
| ball spinball squeezing will be applied after the child comes to the service after the operation and after the postoperative period preparation is made (taking the vital signs, dressing the clothes, controlling the bleeding, telling the feeding time, etc.). | Other | Experiment 1: ball spin |
Primary outcome
pain level of children
Time frame: Just before the interventions and 5 minutes after the intervention
Wong Baker Pain Faces Scale mean score Wong-Baker Pain Faces Scale is widely used with people ages three and older, not limited to children. This self-assessment tool must be understood by the patient, so they are able to choose the face that best illustrates the physical pain they are experiencing. It is a tool to be used by a third person, parents, healthcare professionals, or caregivers, to assess the patient's pain. The scale is 0-10 scale. The six illustrated faces on the cards show a range of emotions, from a smiling face (0 'no pain) to a crying face (10 "worst pain"). 0 indicates no pain, 10 indicates the most severe pain. It is measured before, at the 10th minute and after the intervention.
physiological parametres of the child: body temperature level
Time frame: Just before the interventions and 5 minutes after the intervention
body temperature change
physiological parametres of the child: peak heart rate
Time frame: Just before the interventions and 5 minutes after the intervention
heart rate change
physiological parametres of the child: respiratory rate
Time frame: Just before the interventions and 5 minutes after the intervention
respiratory rate change
physiological parametres of the child: oxygen saturation (SpO2)
Time frame: Just before the interventions and 5 minutes after the intervention
SpO2 level change
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Individual participant dataSharing planned: Yes. The effect of distraction methods on the postoperative period of pediatric patients undergoing outpatient surgery
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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.
Fatma Tas Arslan, professor study director
Selcuk University
Mehmet Sarıkaya, Doctor study chair
Selcuk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Watching Cartoons and ball spin in people with Pain, Postoperative and Surgery, run by Selcuk 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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 19 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sevinc Akkoyun, Phd (+9003322231090, sevincakkoyun87@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain level of children (time frame: Just before the interventions and 5 minutes after the intervention). The study lists 5 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 19 Mar 2024.