NCT05950126

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
197

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 18, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2023

Completed
Last Updated

November 13, 2024

Status Verified

November 1, 2024

Enrollment Period

11 months

First QC Date

July 10, 2023

Last Update Submit

November 10, 2024

Conditions

Keywords

postoperative paincircumcisionpain catastrophizingmotherchildrenVAS

Outcome Measures

Primary Outcomes (1)

  • 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.

    18 month

Study Arms (2)

Group 1

low pain catastrophizing score in mother

Other: pain catastrophizing scala

Group 2

high pain catastrophizing score in mother

Other: pain catastrophizing scala

Interventions

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.

Group 1Group 2

Eligibility Criteria

Age5 Years - 12 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsAmong the children who come to the preoperative anesthesia outpatient clinic with their mothers to undergo elective circumcision will be accepted if their mothers will be agreed to participate in the study. Volunteer mothers at the anesthesia outpatient clinic will be given a questionnaire to fill out and provided informed consent.
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Age 5-12 years,
  • Being operated under general anesthesia.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsun University

Samsun, 55090, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 25558568BACKGROUND

Related Links

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Samsun University

Study Record Dates

First Submitted

July 10, 2023

First Posted

July 18, 2023

Study Start

April 1, 2022

Primary Completion

March 1, 2023

Study Completion

August 20, 2023

Last Updated

November 13, 2024

Record last verified: 2024-11

Locations