Postoperative PainNCT06187688
Measuring Pain Intensity in Cesarean Patients
An observational study of Postoperative Pain, run by Prince of Songkla University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Questionnaire
- How many people
- 209 participants
- Where
- No sites listed yet
- Study dates
- Jan 2024to Dec 2025
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who undergo cesarean delivery.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Measuring Pain Intensity in Cesarean Delivery Patients: a Comparison of 5 Scales
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".
Read the detailed description
- Participants will be invited to participate in this study. If they agree to get involved, they will be provided a printed information sheet that describes the study purposes and procedures. A. The participants will not be disturbed if they are sleeping, caring for their baby or actively receiving a health care service.
- The research team will not ask ward nurses to provide the information sheet to the participants because nurses are already overwhelmed by their assigned jobs to provide nursing care to patients.
- A "research staff person" will describe the purpose and procedures of the study, voluntariness of participation, potential benefits and harms, and rights to withdraw from the study, as also described on the information sheet.
- Research staff persons = anesthetic nurses B. The research team will not ask ward nurses to describe the purpose and procedures of the study to the participants because nurses are already overwhelmed by their assigned jobs to provide nursing care to patients.
- Time will be provided for participants to ask any questions, and the research staff person will answer any questions asked.
- Unlimited time will be provided for the participants to respond to the study questions and complete the study measures. B. The participants can choose to participate on another day during their admission.
- Any individual agreeing to participate will be asked to read and sign an informed consent form.
- Participants will then be asked to provide demographic data and information about their pain (via interview/via a paper-and-pencil questionnaire developed for this purpose). The information gathered will include: age, education level and pain characteristics.
- The participants will be instructed on how to use each assessment tool, and information about the measures will be repeated up to 3 times if requested by a participant.
- The participants will be asked to rate their (1) current pain intensity, (2) maximum/worst pain intensity experienced during the past week, (3) average pain intensity experienced during the past week, and (4) minimum/least pain intensity experienced during the last week, using all five of the aforementioned scales.
- Each type of scale will be presented on a separate page and in random order (using a Latin square design), so those participants are not able to easily refer to their previous responses when responding to each scale.
- Hence, all participants will provide 20 ratings.
- If any participant is unable to use a measure or answers incorrectly to any measurement tool, the administrator will not note any incorrect use while the participants are completing the measures, nor will they attempt to correct any errors made by participants in using the scales (other than to repeat the instructions up to 3 times, if requested by the participant).
- After participants have provided the 20 ratings using the 5 pain measurement tools, they will be asked if they do or do not have a preference for any one type of scale. If they do have a preference, they will be asked to identify the scale that they prefer over the others.
- Participants are asked to describe their pain characteristics using their own words.
- Conditions
- Postoperative Pain
- Being tested
- Questionnaire
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Patients to complete a questionnaire on measurement of pain intensity.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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:
- the VNRS
- the FPS-R
- the VDS
- the NRS
- the VAS
Measured: 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.
To compare the easiness to respond between the newly proposed word (very severe pain) and the previously used word (worst pain imaginable), using percentage of correct response.
Measured: 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.
To compare the easiness to respond between the newly proposed word (overall pain) and the previously used word (average pain), using percentage of correct response.
Measured: January 2024 - December 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2024
- Study startJan 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 209 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sasikaan Nimmaanrat, Prince of Songkla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06187688
- Sponsor's protocol ID
- 66-355-8-1
- Status last verified
- Dec 2023
- First submitted
- 15 Dec 2023
- Last updated
- 2 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD will be shared upon request.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Pain Intensity in Cesarean Delivery Patients: a Comparison of 5 Scales
- ClinicalTrials.gov ID
- NCT06187688
- Acronym / sponsor ID
- 66-355-8-1
- Conditions
- Postoperative Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 209 participants (estimated)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 2 Jan 2024 (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.
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".
Detailed description
- Participants will be invited to participate in this study. If they agree to get involved, they will be provided a printed information sheet that describes the study purposes and procedures. A. The participants will not be disturbed if they are sleeping, caring for their baby or actively receiving a health care service.
- The research team will not ask ward nurses to provide the information sheet to the participants because nurses are already overwhelmed by their assigned jobs to provide nursing care to patients.
- A "research staff person" will describe the purpose and procedures of the study, voluntariness of participation, potential benefits and harms, and rights to withdraw from the study, as also described on the information sheet.
- Research staff persons = anesthetic nurses B. The research team will not ask ward nurses to describe the purpose and procedures of the study to the participants because nurses are already overwhelmed by their assigned jobs to provide nursing care to patients.
- Time will be provided for participants to ask any questions, and the research staff person will answer any questions asked.
- Unlimited time will be provided for the participants to respond to the study questions and complete the study measures. B. The participants can choose to participate on another day during their admission.
- Any individual agreeing to participate will be asked to read and sign an informed consent form.
- Participants will then be asked to provide demographic data and information about their pain (via interview/via a paper-and-pencil questionnaire developed for this purpose). The information gathered will include: age, education level and pain characteristics.
- The participants will be instructed on how to use each assessment tool, and information about the measures will be repeated up to 3 times if requested by a participant.
- The participants will be asked to rate their (1) current pain intensity, (2) maximum/worst pain intensity experienced during the past week, (3) average pain intensity experienced during the past week, and (4) minimum/least pain intensity experienced during the last week, using all five of the aforementioned scales.
- Each type of scale will be presented on a separate page and in random order (using a Latin square design), so those participants are not able to easily refer to their previous responses when responding to each scale.
- Hence, all participants will provide 20 ratings.
- If any participant is unable to use a measure or answers incorrectly to any measurement tool, the administrator will not note any incorrect use while the participants are completing the measures, nor will they attempt to correct any errors made by participants in using the scales (other than to repeat the instructions up to 3 times, if requested by the participant).
- After participants have provided the 20 ratings using the 5 pain measurement tools, they will be asked if they do or do not have a preference for any one type of scale. If they do have a preference, they will be asked to identify the scale that they prefer over the others.
- Participants are asked to describe their pain characteristics using their own words.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who undergo cesarean delivery.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| QuestionnairePatients to complete a questionnaire on measurement of pain intensity. | Other | – |
Primary outcome
To evaluate the psychometric properties of the Verbal 11-point Numerical Rating Score (VNRS) in cesarean section patients.
Time frame: January 2024 - December 2025
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.
To evaluate the psychometric properties of the Faces Pain Scale - Revised (FPS-R) in cesarean section patients.
Time frame: January 2024 - December 2025
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.
To evaluate the psychometric properties of the 6-point Verbal Descriptive Scale (VDS) in cesarean section patients.
Time frame: January 2024 - December 2025
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.
To evaluate the psychometric properties of the 11-point Numerical Rating Scale (NRS) in cesarean section patients.
Time frame: January 2024 - December 2025
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.
To evaluate the psychometric properties of the 100 mm Visual Analog Scale (VAS) in cesarean section patients.
Time frame: January 2024 - December 2025
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.
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.
Time frame: January 2024 - December 2025
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
2 secondary outcomes
To compare the easiness to respond between the newly proposed words and the previously used words, using percentage of correct response.
Time frame: 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.
Time frame: January 2024 - December 2025
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
- Individual participant dataSharing planned: Undecided. IPD will be shared upon request.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain, run by Prince of Songkla University.
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 4 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: status not confirmed, as of the sponsor's last update on 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sasikaan Nimmaanrat, MD, MMed (+66887907842, snimmaanrat@yahoo.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the psychometric properties of the Verbal 11-point Numerical Rating Score (VNRS) in cesarean section patients. (time frame: January 2024 - December 2025). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jan 2024.