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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05950126
Other study ID # B.30.2.ODM.0.20.08/80-165
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 1, 2022
Est. completion date August 20, 2023

Study information

Verified date July 2023
Source Samsun University
Contact Sevda Akdeniz
Phone +905053998651
Email sevakdeniz@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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).


Description:

Now, the study is continuing.


Recruitment information / eligibility

Status Recruiting
Enrollment 197
Est. completion date August 20, 2023
Est. primary completion date August 1, 2023
Accepts healthy volunteers No
Gender Male
Age group 5 Years to 12 Years
Eligibility Inclusion Criteria: - Age 5-12 years, - Being operated under general anesthesia. Exclusion Criteria: - 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).

Study Design


Related Conditions & MeSH terms


Intervention

Other:
pain catastrophizing scala
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.

Locations

Country Name City State
Turkey Samsun University Samsun

Sponsors (1)

Lead Sponsor Collaborator
Samsun University

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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