Pain CatastrophizingNCT05950126
Maternal Pain Catastrophizing Score is Related With Children's Postoperative Circumcision Pain
An observational study of Pain Catastrophizing, run by Sevda Akdeniz,MD at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to evaluate the relation of maternal pain catastrophizing score with child's who underwent circumcision postoperative pain. A cross-sectional study and this study was performed at the Samsun University, Samsun Training and Research Hospital, Samsun, Türkiye. Read more about this study
- Who is it for?
- Ages 5 to 12 years, men only
- Conditions the study is for
- Pain Catastrophizing
- What is being tested?
- pain catastrophizing scala
- How many people
- 197 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 20 Aug 2023
- How long will I take part?
- 1 Year
- 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 5 to 12 years
- Men only
- No healthy volunteers
- Child
Study population: Among the children who come to the preoperative anesthesia outpatient clinic with their mothers to undergo elective circumcision will be accepted if their mothers agreed to participate in the study.
Who may be able to join
- Age 5-12 years,
- Being operated under general anesthesia.
Who cannot join
- Children without biological mothers, or with a parent other than the mother,
- Children aged under five or over 12,
- History of previous surgery,
- Being operated under regional anesthesia,
- Use of analgesic, antiepileptic, or sedative medications, and
- Other procedures being performed in addition to circumcision (such as herniorrhaphy, tonsillectomy, orchiopexy, and appendectomy).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Pain Perception Communicated Through Mothers? Maternal Pain Catastrophizing Score is Related With Children's Postoperative Circumcision Pain
The aim of this study was to evaluate the relation of maternal pain catastrophizing score with child's who underwent circumcision postoperative pain. A cross-sectional study and this study was performed at the Samsun University, Samsun Training and Research Hospital, Samsun, Türkiye. The mothers were divided into low pain catastrophizing (Group 1) and high pain catastrophizing (Group 2) group. Children's postoperative pain intensity was measured using the visual analog scale (VAS) and a faces pain scale (FPS).
Read the detailed description
Now, the study is continuing.
- Conditions
- Pain Catastrophizing
- Being tested
- pain catastrophizing scala
- Keywords
- postoperative pain, circumcision, pain catastrophizing, mother, children, VAS
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pain catastrophizing scalaOther
The PCS, a 13-item self-report inventory used to determine the extent to which individuals catastrophize in response to pain, was developed. Total possible scores range from 0 to 52, with higher scores indicating negative results.
The Turkish version was tested for reliability and validity and the Cronbach alpha coefficient was measured at 0.90. PCS scores of 16 or lower are regarded as normal, and scores of 17 or above as high.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | low pain catastrophizing score in mother Receives: Other: pain catastrophizing scala | |
| Group 2 | high pain catastrophizing score in mother Receives: Other: pain catastrophizing scala |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCS, mother, and child
Authors will be investigated the relationship between maternal pain catastrophizing score levels and the postoperative pain experienced by the child. Empathy towards pain is necessary to notice, understand, and respond to another person's pain. Children develop empathy towards pain over time, which may be related to social learning.
Pain Catastrophizing scale (PCS): The PCS is a self-assessment questionnaire to examine catastrophizing in clinical and nonclinical populations. The PCS consists of 13 statements containing a number of thoughts and feelings one may experience when having pain. The items are divided into the categories of rumination, magnification and helplessness, with each item scored on a 5-point scale, from 0 (not at all) to 4 (always), people are asked to rate how often they experience the mentioned thoughts and feelings when they are in pain. The overall score has a range of 0-52.
Measured: 18 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start1 Apr 2022
- Primary completion1 Mar 2023
- Study completion20 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain CatastrophizingStudies 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
- 197 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Sevda Akdeniz,MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sevda Akdeniz,MD, Samsun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05950126
- Sponsor's protocol ID
- B.30.2.ODM.0.20.08/80-165
- Status last verified
- Nov 2024
- First submitted
- 10 Jul 2023
- Last updated
- 13 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Suren M, Okan I, Gokbakan AM, Kaya Z, Erkorkmaz U, Arici S, Karaman S, Kahveci M. Factors associated with the pain catastrophizing scale and validation in a sample of the Turkish population. Turk J Med Sci. 2014;44(1):104-8. doi: 10.3906/sag-1206-67.
PubMed 25558568
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Pain Perception Communicated Through Mothers? Maternal Pain Catastrophizing Score is Related With Children's Postoperative Circumcision Pain
- ClinicalTrials.gov ID
- NCT05950126
- Acronym / sponsor ID
- B.30.2.ODM.0.20.08/80-165
- Conditions
- Pain Catastrophizing
- Keywords
- postoperative pain, circumcision, pain catastrophizing, mother, children, VAS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Sevda Akdeniz,MDUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 20 Aug 2023 (actual)
- First posted
- 18 Jul 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 this study was to evaluate the relation of maternal pain catastrophizing score with child's who underwent circumcision postoperative pain. A cross-sectional study and this study was performed at the Samsun University, Samsun Training and Research Hospital, Samsun, Türkiye. The mothers were divided into low pain catastrophizing (Group 1) and high pain catastrophizing (Group 2) group. Children's postoperative pain intensity was measured using the visual analog scale (VAS) and a faces pain scale (FPS).
Detailed description
Now, the study is continuing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: pain catastrophizing scalalow pain catastrophizing score in mother |
| Group 2 | – | Other: pain catastrophizing scalahigh pain catastrophizing score in mother |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Among the children who come to the preoperative anesthesia outpatient clinic with their mothers to undergo elective circumcision will be accepted if their mothers agreed to participate in the study.
Key inclusion criteria (2 listed)
- Age 5-12 years,
- Being operated under general anesthesia.
Key exclusion criteria (6 listed)
- Children without biological mothers, or with a parent other than the mother,
- Children aged under five or over 12,
- History of previous surgery,
- Being operated under regional anesthesia,
- Use of analgesic, antiepileptic, or sedative medications, and
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 |
|---|---|---|
| pain catastrophizing scalaThe PCS, a 13-item self-report inventory used to determine the extent to which individuals catastrophize in response to pain, was developed. Total possible scores range from 0 to 52, with higher scores indicating negative results. The Turkish version was tested for reliability and validity and the Cronbach alpha coefficient was measured at 0.90. PCS scores of 16 or lower are regarded as normal, and scores of 17 or above as high. | Other | Group 1, Group 2 |
Primary outcome
PCS, mother, and child
Time frame: 18 month
Authors will be investigated the relationship between maternal pain catastrophizing score levels and the postoperative pain experienced by the child. Empathy towards pain is necessary to notice, understand, and respond to another person's pain. Children develop empathy towards pain over time, which may be related to social learning. Pain Catastrophizing scale (PCS): The PCS is a self-assessment questionnaire to examine catastrophizing in clinical and nonclinical populations. The PCS consists of 13 statements containing a number of thoughts and feelings one may experience when having pain. The items are divided into the categories of rumination, magnification and helplessness, with each item scored on a 5-point scale, from 0 (not at all) to 4 (always), people are asked to rate how often they experience the mentioned thoughts and feelings when they are in pain. The overall score has a range of 0-52.
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 13 Nov 2024.
- Background: PubMed 25558568Suren M, Okan I, Gokbakan AM, Kaya Z, Erkorkmaz U, Arici S, Karaman S, Kahveci M. Factors associated with the pain catastrophizing scale and validation in a sample of the Turkish population. Turk J Med Sci. 2014;44(1):104-8. doi: 10.3906/sag-1206-67.
- Reference articleLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Pain Catastrophizing, run by Sevda Akdeniz,MD 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 2 inclusion and 6 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 13 Nov 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?
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?
PCS, mother, and child (time frame: 18 month). 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 NCT05950126, which also lists 1 linked publication.
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 13 Nov 2024.