Measuring Pain Intensity in Cesarean Patients

NCT06187688 | Unknown DMC

• 1 other identifier: 66-355-8-1
• Study Type: observational
• Target: 209
• Locations: 0 countries
• Sites: N/A

Brief Summary

Pain intensity is commonly measured in research and clinical settings. Primary objective: To evaluate psychometric properties (validity, reliability, and utility) of 5 pain measurement tools: a verbal 11-point NRS, the FPS-R, a 6-point VDS, an 11-point NRS, and a 100 mm VAS in a sample of cesarean section patients. Secondary objectives: To evaluate whether the (new) word "very severe pain" is easier for patients to understand in comparison to the (old) word "worst pain imaginable. To evaluate whether the (new) word "overall pain" is easier for patients to understand in comparison to the (old) word "average pain".

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (6)

• To evaluate the psychometric properties of the Verbal 11-point Numerical Rating Score (VNRS) in cesarean section patients.

  To evaluate the psychometric properties of the 11-point Verbal Numerical Rating Score (VNRS) which 0 means "no pain" and 10 means "worst pain imaginable" in a sample of cesarean section patients.

  January 2024 - December 2025

• To evaluate the psychometric properties of the Faces Pain Scale - Revised (FPS-R) in cesarean section patients.

  To evaluate the psychometric properties of the Faces Pain Scale - Revised (FPS-R) which comprises with 6 faces ranging from the first neutral face as "no pain" and the sixth face as "the most severe pain" in a sample of cesarean section patients.

  January 2024 - December 2025

• To evaluate the psychometric properties of the 6-point Verbal Descriptive Scale (VDS) in cesarean section patients.

  To evaluate the psychometric properties of the 6-point Verbal Descriptive Scale (VDS) ranging from no pain, very mild pain, mild pain, moderate pain, severe pain and very severe pain in a sample of cesarean section patients.

  January 2024 - December 2025

• To evaluate the psychometric properties of the 11-point Numerical Rating Scale (NRS) in cesarean section patients.

  To evaluate the psychometric properties of the 11-point Numerical Rating Scale (NRS) where 0 means "no pain" and 10 means "worst imaginable pain" in a sample of cesarean section patients.

  January 2024 - December 2025

• To evaluate the psychometric properties of the 100 mm Visual Analog Scale (VAS) in cesarean section patients.

  To evaluate the psychometirc properties of the 100 mm Visual Analog Scale (VAS) where 0 mm (left end of the line) represents "no pain" and 100 mm (right end of the line) represents "worst pain imaginable" in a sample of cesarean section patients.

  January 2024 - December 2025

• To directly compare the psychometric properties of 5 pain measurement tools (VNRS, FPS-R, VDS, NRS and VAS in a sample of cesarean section patients.

  To directly compare the psychometric properties of 5 pain measurement tools in a sample of cesarean section patients: 1. the VNRS 2. the FPS-R 3. the VDS 4. the NRS 5. the VAS

  January 2024 - December 2025

Secondary Outcomes (2)

• To compare the easiness to respond between the newly proposed words and the previously used words, using percentage of correct response.

  January 2024 - December 2025

• To compare the easiness to respond between the newly proposed words and the previously used words, using percentage of correct response.

  January 2024 - December 2025

Interventions

Questionnaire OTHER

Patients to complete a questionnaire on measurement of pain intensity.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who undergo cesarean delivery.

You may qualify if:

• Age ≥ 18 years old
• Endorsing having post-cesarean section pain in the first 72 hrs following the operation
• Can speak and write in Thai, as determined by an ability to answer details about demographic information
• No motor deficits in the hands that would interfere with their ability to respond to a paper-and-pencil questionnaire

You may not qualify if:

• Age less than 18 years old
• Lack of fluency in Thai
• Neurological disorder or psychiatric illness that would interfere with participation or ability to provide informed consent
• Refusal to participate in the study

Sponsors & Collaborators

• Prince of Songkla University: lead

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Sasikaan Nimmaanrat, MD, MMed

CONTACT

+66887907842; snimmaanrat@yahoo.com.au

Boonsin Tangtrakulwanich, MD

CONTACT

+6674451149; medpsu.ec@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 15, 2023
• First Posted: January 2, 2024
• Study Start: January 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: January 2, 2024

Record last verified: 2023-12