Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06187688
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-02
First Post:
2023-12-15
Brief Title:
Measuring Pain Intensity in Cesarean Patients
Sponsor:
Prince of Songkla University
Organization:
Prince of Songkla University
Study Overview
Official Title:
Measuring Pain Intensity in Cesarean Delivery Patients a Comparison of 5 Scales
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
1 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
B 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
2 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
A 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
3 Time will be provided for participants to ask any questions and the research staff person will answer any questions asked
A 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
4 Any individual agreeing to participate will be asked to read and sign an informed consent form
5 Participants will then be asked to provide demographic data and information about their pain via interviewvia a paper-and-pencil questionnaire developed for this purpose The information gathered will include age education level and pain characteristics
6 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
7 The participants will be asked to rate their 1 current pain intensity 2 maximumworst pain intensity experienced during the past week 3 average pain intensity experienced during the past week and 4 minimumleast pain intensity experienced during the last week using all five of the aforementioned scales
8 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
9 Hence all participants will provide 20 ratings
10 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
11 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
12 Participants are asked to describe their pain characteristics using their own words
B 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
2 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
A 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
3 Time will be provided for participants to ask any questions and the research staff person will answer any questions asked
A 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
4 Any individual agreeing to participate will be asked to read and sign an informed consent form
5 Participants will then be asked to provide demographic data and information about their pain via interviewvia a paper-and-pencil questionnaire developed for this purpose The information gathered will include age education level and pain characteristics
6 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
7 The participants will be asked to rate their 1 current pain intensity 2 maximumworst pain intensity experienced during the past week 3 average pain intensity experienced during the past week and 4 minimumleast pain intensity experienced during the last week using all five of the aforementioned scales
8 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
9 Hence all participants will provide 20 ratings
10 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
11 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
12 Participants are asked to describe their pain characteristics using their own words
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None