Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06024044 |
Other study ID # |
2022/P428 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
May 12, 2022 |
Est. completion date |
June 15, 2023 |
Study information
Verified date |
September 2023 |
Source |
Trakya University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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 (i.e.,
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 (1:1 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
(B.K) 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
0.6307060, 95% confidence level, and 80% power. Power analysis of the study was performed
with G*POWER 3.1.9.7 (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.