Ignite Creation Date:
2024-05-06 @ 7:28 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06024044
Status:
COMPLETED
Last Update Posted:
2023-09-07
First Post:
2023-08-29
Brief Title:
Effect of Mobilization Training Given to Hysterectomy Operation on Bottom Functions and Pain
Sponsor:
Trakya University
Organization:
Trakya University
Study Overview
Official Title:
The Effect of Mobilization Training Given to Women Before the Hysterectomy Operation on Post-Operational Bottom Functions and Pain A Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2023-09
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:
Objectives Research on the effect of mobilization training given to women before the hysterectomy operation on post-operational bottom functions and pain is a new and promising feld of research However high-level evidence on whether mobilization and mobilization training has an effect on bowel function and pain is insufficient The present study addresses this research question
Design A two-arm randomized controlled trial was conducted in 82 women patients
Design A two-arm randomized controlled trial was conducted in 82 women patients
Detailed Description:
This two-arm randomized controlled trial RCT was conducted in the women patients undergoing hysterectomy located in Edirne between May 2022 and June 2023 During the intake the women patients undergoing hysterectomy were informed about the goals and setup of the study and intervention and assessed for eligibility by a brief standardized interview The women patients undergoing hysterectomy who fulfilled our criteria received an information letter and informed consent form as well as the baseline questionnaire Those women patients undergoing hysterectomy that provided written informed consent for participation were included in the study Assessments in both groups were performed before randomization ie baseline and directly after the intervention period
Randomization The women patients undergoing hysterectomy were randomly assigned to an education or control groups A research assistant not actively involved in the design and data analysis of the study created a random distribution sequence and assigned participants to one of the two conditions 11 ratio
Intervention
Mobilization Training A face-to-face Patient Information Form was applied to the training group in the first interview before the hysterectomy operation The participants in the training group were given hysterectomy postoperative mobilization training by the researcher BK using presentation and verbal information technique A Post-Operative Follow-up Chart was given to the participants to fill in the 1st and 2nd postoperative days The training group participants were followed up by the researcher on the 0th and 1st days after the operation in line with the mobilization training they received The Post-Operative Follow-up Chart questioning the patients mobilization times distances bowel functions and pain scores was filled in by the researcher in detail by face-to-face interview method Mobilization time minutes and distance meters were evaluated by the patients and their relatives and recorded on the chart using the stopwatch and pedometer on the personal mobile phones of the patients
Control Group The women patients in the control group who underwent hysterectomy were informed that mobilization training would be performed after a postoperative 2-day waiting period Meanwhile no intervention was made except for any routine nursing care
Measures Patient Information Form and Post-Operative Follow-up Chart were used in the study Patient Information Form It was created by the researchers by scanning the literature and consists of a total of 18 questions including 6 questions about the personal characteristics of the participants 3 questions about the obstetric and surgical characteristics and 9 questions about the postoperative results Postoperative Follow-up Chart It was created by the researchers by scanning the literature and consists of a 24-hour chart including the 0 and 1 postoperative day mobilization time mobilization distance pain score gas and stool output time of the participants
Sample size calculation for the primary research question was performed based on a pilot study Tharwat et al 2021 within the scope of the findings of their study named Impact of Sugarless Chewing gum Versus Peppermint on First Bowel Movement after Cesarean Section Randomized Controlled Trial sample calculation was made by predicting the effect size of 06307060 95 confidence level and 80 power Power analysis of the study was performed with GPOWER 3197 Power analysis statistical software program Faul et al 2021 A total of 82 women with hysterectomy Training group 41 women Control group 41 women constituted the sample
Randomization The women patients undergoing hysterectomy were randomly assigned to an education or control groups A research assistant not actively involved in the design and data analysis of the study created a random distribution sequence and assigned participants to one of the two conditions 11 ratio
Intervention
Mobilization Training A face-to-face Patient Information Form was applied to the training group in the first interview before the hysterectomy operation The participants in the training group were given hysterectomy postoperative mobilization training by the researcher BK using presentation and verbal information technique A Post-Operative Follow-up Chart was given to the participants to fill in the 1st and 2nd postoperative days The training group participants were followed up by the researcher on the 0th and 1st days after the operation in line with the mobilization training they received The Post-Operative Follow-up Chart questioning the patients mobilization times distances bowel functions and pain scores was filled in by the researcher in detail by face-to-face interview method Mobilization time minutes and distance meters were evaluated by the patients and their relatives and recorded on the chart using the stopwatch and pedometer on the personal mobile phones of the patients
Control Group The women patients in the control group who underwent hysterectomy were informed that mobilization training would be performed after a postoperative 2-day waiting period Meanwhile no intervention was made except for any routine nursing care
Measures Patient Information Form and Post-Operative Follow-up Chart were used in the study Patient Information Form It was created by the researchers by scanning the literature and consists of a total of 18 questions including 6 questions about the personal characteristics of the participants 3 questions about the obstetric and surgical characteristics and 9 questions about the postoperative results Postoperative Follow-up Chart It was created by the researchers by scanning the literature and consists of a 24-hour chart including the 0 and 1 postoperative day mobilization time mobilization distance pain score gas and stool output time of the participants
Sample size calculation for the primary research question was performed based on a pilot study Tharwat et al 2021 within the scope of the findings of their study named Impact of Sugarless Chewing gum Versus Peppermint on First Bowel Movement after Cesarean Section Randomized Controlled Trial sample calculation was made by predicting the effect size of 06307060 95 confidence level and 80 power Power analysis of the study was performed with GPOWER 3197 Power analysis statistical software program Faul et al 2021 A total of 82 women with hysterectomy Training group 41 women Control group 41 women constituted the sample
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