Postoperative PainPSE-PAIN-MSNCT07381673
Parental Self-Efficacy for Child Autonomy and Postoperative Pain in Children Undergoing Minor Surgery
An observational study of Postoperative Pain, run by Agri Ibrahim Cecen University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to examine the relationship between parental self-efficacy in supporting child autonomy and postoperative pain levels in children undergoing minor surgical procedures. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Postoperative Pain
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2026to 10 May 2026
- Phase
- Observational
- 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study population consists of children aged 3 to 18 years undergoing minor surgical procedures and their parents or legal guardians at a single state hospital in Turkey.
Who may be able to join
- Children aged 3 to 18 years
- Scheduled for minor surgical procedures
- Able to understand and respond to age-appropriate pain assessment tools
- Parents or legal guardians able to read and understand Turkish
- Written informed consent obtained from parents or legal guardians
Who cannot join
- Presence of chronic pain conditions
- Neurological or cognitive disorders that may interfere with pain assessment
- Requirement for postoperative intensive care
- Incomplete completion of data collection forms
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dogubayazit State Hospital
Ağrı, Dogubeyazit, 04400
About this study
Official title: The Effect of Parental Self-Efficacy for Child Autonomy on Postoperative Pain in Children Undergoing Minor Surgery
This study aims to examine the relationship between parental self-efficacy in supporting child autonomy and postoperative pain levels in children undergoing minor surgical procedures. The study will be conducted with children aged 3 to 18 years and their parents at a single hospital in Turkey.Participation in the study is voluntary. Parents will be asked to complete questionnaires assessing their confidence in supporting their child's autonomy during the surgical process. Children's postoperative pain levels will be assessed using an age-appropriate pain rating scale during the early postoperative period.No experimental treatment or additional medical procedures will be performed as part of this study. All data will be collected as part of routine care and questionnaire assessments. The results of this study are expected to contribute to improved family-centered perioperative care for children undergoing minor surgery.
Read the detailed description
This prospective observational study is designed to investigate the relationship between parental self-efficacy for supporting child autonomy and postoperative pain levels in children undergoing minor surgical procedures.
The study population consists of children aged 3 to 18 years who are scheduled for minor surgery and their parents or legal guardians. Data will be collected at a single tertiary-level state hospital in Turkey. Participation is based on voluntary informed consent obtained from parents, and age-appropriate assent will be obtained from children when applicable.
Parental self-efficacy related to supporting child autonomy during the surgical process will be assessed preoperatively using the Parental Self-Efficacy Scale for Child Autonomy Toward Minor Surgery, a validated questionnaire. Postoperative pain intensity in children will be assessed during the early postoperative period using the Wong-Baker FACES Pain Rating Scale at predefined time points.
No interventions beyond standard clinical care will be implemented as part of the study. The study does not involve the use of investigational drugs, devices, or experimental procedures. All clinical care, including pain management, will be provided according to routine hospital protocols.
Descriptive statistics will be used to summarize participant characteristics and scale scores. The relationship between parental self-efficacy and postoperative pain levels will be analyzed using appropriate correlational and regression-based statistical methods. The findings are expected to support the development of family-centered perioperative nursing approaches aimed at improving postoperative pain outcomes in children undergoing minor surgery.
- Conditions
- Postoperative Pain
- Keywords
- Parental Self-Efficacy, Child Autonomy, Postoperative Pain, Minor Surgery, Pediatric Nursing, Family-Centered Care
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children Undergoing Minor Surgery | This cohort includes children aged 3 to 18 years undergoing minor surgical procedures and their parents. Participants are observed prospectively to assess parental self-efficacy for supporting child autonomy and children's postoperative pain levels. No intervention beyond routine clinical care is applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Level
Postoperative pain intensity measured using the Wong-Baker FACES Pain Rating Scale, scored from 0 (no pain) to 10 (severe pain). Pain assessments will be conducted at multiple predefined time points during the early postoperative period.
Measured: At 0, 2, and 6 hours after surgery
Secondary outcomes (1)
Parental Self-Efficacy for Child Autonomy
Parental self-efficacy assessed using the Parental Self-Efficacy Scale for Child Autonomy Toward Minor Surgery, an 18-item Likert-type scale with scores ranging from 1 to 4, where higher total scores indicate higher parental self-efficacy.
Measured: Preoperative period, prior to surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start1 Jan 2026
- Primary completion1 May 2026
- Study completion10 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agri Ibrahim Cecen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Volkan Gokmen, Agri Ibrahim Cecen University
- Investigators
- Volkan GOKMEN, Doctorate, Principal investigator, Agri ibrahim Cecen Univercity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07381673
- Sponsor's protocol ID
- AICU-MS-PAIN-2026
- Acronym
- PSE-PAIN-MS
- Status last verified
- May 2026
- First submitted
- 25 Jan 2026
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study involves a pediatric population and includes sensitive health-related information collected from children and their parents. Data are collected solely for the purposes defined in the approved study protocol, and sharing individual-level data could compromise participant confidentiality and privacy.
Publications
Polkki T, Pietila AM, Vehvilainen-Julkunen K, Laukkala H, Ryhanen P. Parental views on participation in their child's pain relief measures and recommendations to health care providers. J Pediatr Nurs. 2002 Aug;17(4):270-8. doi: 10.1053/jpdn.2002.126714.
PubMed 12219326Semerci R, Unver S, Yildizeli Topcu S, Turan FN, Akgun Kostak M, Yildiz Findik U. Adaptation of Parental Self-Efficacy Scale for Child Autonomy Toward Minor Surgery to Turkish. J Perianesth Nurs. 2022 Oct;37(5):632-639. doi: 10.1016/j.jopan.2021.06.098. Epub 2022 May 7.
PubMed 35537932Calcaterra V, Ostuni S, Bonomelli I, Mencherini S, Brunero M, Zambaiti E, Mannarino S, Larizza D, Albertini R, Tinelli C, Pelizzo G. Music benefits on postoperative distress and pain in pediatric day care surgery. Pediatr Rep. 2014 Sep 29;6(3):5534. doi: 10.4081/pr.2014.5534. eCollection 2014 Aug 12.
PubMed 25635217Cai Y, Lopata L, Roh A, Huang M, Monteleone MA, Wang S, Sun LS. Factors influencing postoperative pain following discharge in pediatric ambulatory surgery patients. J Clin Anesth. 2017 Jun;39:100-104. doi: 10.1016/j.jclinane.2017.03.033. Epub 2017 Apr 1.
PubMed 28494878
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Parental Self-Efficacy for Child Autonomy on Postoperative Pain in Children Undergoing Minor Surgery
- ClinicalTrials.gov ID
- NCT07381673
- Acronym / sponsor ID
- PSE-PAIN-MS / AICU-MS-PAIN-2026
- Conditions
- Postoperative Pain
- Keywords
- Parental Self-Efficacy, Child Autonomy, Postoperative Pain, Minor Surgery, Pediatric Nursing, Family-Centered Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Agri Ibrahim Cecen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 10 May 2026 (actual)
- First posted
- 2 Feb 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 examine the relationship between parental self-efficacy in supporting child autonomy and postoperative pain levels in children undergoing minor surgical procedures. The study will be conducted with children aged 3 to 18 years and their parents at a single hospital in Turkey.Participation in the study is voluntary. Parents will be asked to complete questionnaires assessing their confidence in supporting their child's autonomy during the surgical process. Children's postoperative pain levels will be assessed using an age-appropriate pain rating scale during the early postoperative period.No experimental treatment or additional medical procedures will be performed as part of this study. All data will be collected as part of routine care and questionnaire assessments. The results of this study are expected to contribute to improved family-centered perioperative care for children undergoing minor surgery.
Detailed description
This prospective observational study is designed to investigate the relationship between parental self-efficacy for supporting child autonomy and postoperative pain levels in children undergoing minor surgical procedures.
The study population consists of children aged 3 to 18 years who are scheduled for minor surgery and their parents or legal guardians. Data will be collected at a single tertiary-level state hospital in Turkey. Participation is based on voluntary informed consent obtained from parents, and age-appropriate assent will be obtained from children when applicable.
Parental self-efficacy related to supporting child autonomy during the surgical process will be assessed preoperatively using the Parental Self-Efficacy Scale for Child Autonomy Toward Minor Surgery, a validated questionnaire. Postoperative pain intensity in children will be assessed during the early postoperative period using the Wong-Baker FACES Pain Rating Scale at predefined time points.
No interventions beyond standard clinical care will be implemented as part of the study. The study does not involve the use of investigational drugs, devices, or experimental procedures. All clinical care, including pain management, will be provided according to routine hospital protocols.
Descriptive statistics will be used to summarize participant characteristics and scale scores. The relationship between parental self-efficacy and postoperative pain levels will be analyzed using appropriate correlational and regression-based statistical methods. The findings are expected to support the development of family-centered perioperative nursing approaches aimed at improving postoperative pain outcomes in children undergoing minor surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children Undergoing Minor Surgery | – | –This cohort includes children aged 3 to 18 years undergoing minor surgical procedures and their parents. Participants are observed prospectively to assess parental self-efficacy for supporting child autonomy and children's postoperative pain levels. No intervention beyond routine clinical care is applied. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study population consists of children aged 3 to 18 years undergoing minor surgical procedures and their parents or legal guardians at a single state hospital in Turkey.
Key inclusion criteria (5 listed)
- Children aged 3 to 18 years
- Scheduled for minor surgical procedures
- Able to understand and respond to age-appropriate pain assessment tools
- Parents or legal guardians able to read and understand Turkish
- Written informed consent obtained from parents or legal guardians
Key exclusion criteria (4 listed)
- Presence of chronic pain conditions
- Neurological or cognitive disorders that may interfere with pain assessment
- Requirement for postoperative intensive care
- Incomplete completion of data collection forms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative Pain Level
Time frame: At 0, 2, and 6 hours after surgery
Postoperative pain intensity measured using the Wong-Baker FACES Pain Rating Scale, scored from 0 (no pain) to 10 (severe pain). Pain assessments will be conducted at multiple predefined time points during the early postoperative period.
1 secondary outcome
Parental Self-Efficacy for Child Autonomy
Time frame: Preoperative period, prior to surgery
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 27 May 2026.
- Background: PubMed 12219326Polkki T, Pietila AM, Vehvilainen-Julkunen K, Laukkala H, Ryhanen P. Parental views on participation in their child's pain relief measures and recommendations to health care providers. J Pediatr Nurs. 2002 Aug;17(4):270-8. doi: 10.1053/jpdn.2002.126714.
- Background: PubMed 35537932Semerci R, Unver S, Yildizeli Topcu S, Turan FN, Akgun Kostak M, Yildiz Findik U. Adaptation of Parental Self-Efficacy Scale for Child Autonomy Toward Minor Surgery to Turkish. J Perianesth Nurs. 2022 Oct;37(5):632-639. doi: 10.1016/j.jopan.2021.06.098. Epub 2022 May 7.
- Background: PubMed 25635217Calcaterra V, Ostuni S, Bonomelli I, Mencherini S, Brunero M, Zambaiti E, Mannarino S, Larizza D, Albertini R, Tinelli C, Pelizzo G. Music benefits on postoperative distress and pain in pediatric day care surgery. Pediatr Rep. 2014 Sep 29;6(3):5534. doi: 10.4081/pr.2014.5534. eCollection 2014 Aug 12.
- Background: PubMed 28494878Cai Y, Lopata L, Roh A, Huang M, Monteleone MA, Wang S, Sun LS. Factors influencing postoperative pain following discharge in pediatric ambulatory surgery patients. J Clin Anesth. 2017 Jun;39:100-104. doi: 10.1016/j.jclinane.2017.03.033. Epub 2017 Apr 1.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study involves a pediatric population and includes sensitive health-related information collected from children and their parents. Data are collected solely for the purposes defined in the approved study protocol, and sharing individual-level data could compromise participant confidentiality and privacy.
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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.
Volkan GOKMEN, Doctorate principal investigator
Agri ibrahim Cecen Univercity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain, run by Agri Ibrahim Cecen 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 4 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 27 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?
Postoperative Pain Level (time frame: At 0, 2, and 6 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07381673, which also lists 4 linked publications.
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 27 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.