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MobilizationNCT06024044

Effect of Mobilization Training Given to Hysterectomy Operation on Bottom Functions and Pain

A study testing Mobilization Training in people with Mobilization and Training Group, run by Trakya University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Mobilization, Training Group
What is being tested?
Mobilization Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
1 siteTurkey (Türkiye)
Study dates
12 May 2022to 15 Jun 2023
Phase
Interventional
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Having hysterectomy surgery,
  • At least primary school graduate,
  • With good mental functions,
  • Not experiencing serious depression, anxiety and stress,
  • No serious postoperative complications,
  • No chronic pain,
  • No sensory problems (vision loss, auditory loss, etc.),
  • Women who volunteered to participate in the study.

Who cannot join

  • Diagnosed with depression, anxiety and stress disorder,
  • Diagnosed with chronic pain,
  • Women who did not volunteer to participate in the study

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Trakya University

    Edirne

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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 (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.

Being tested
Mobilization Training
Keywords
Hysterectomy, Women, Post-Operational, Bottom Functions, Pain, Mobilization Training
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mobilization TrainingBehavioural

    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.

Study groups in NCT06024044
Study groupRoleWhat they receive
ControlNo interventionThe 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.
Mobilization TrainingExperimentalA 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.
Receives: Behavioral: Mobilization Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain evaluated using the Visual Analog Scale

    The intensity of pain is measured using the VAS, a valid and reliable tool for measuring experimental and clinical pain. The VAS is scored on a horizontal line of 10 cm (0=no pain and 10=worst possible pain).

    Measured: change from baseline implamentation patent and after 0 and 1 postoperative day of practice.

Secondary outcomes (1)
  1. Bottom functions evaluated using the 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.

    Measured: change from baseline implamentation patent and after 0 and 1 postoperative day of practice.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2023
  2. Study start12 May 2022
  3. Primary completion14 May 2022
  4. Study completion15 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06024044
Sponsor's protocol ID
2022/P428
Status last verified
Sep 2023
First submitted
29 Aug 2023
Last updated
7 Sep 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Mobilization Training in people with Mobilization and Training Group, run by Trakya University at 1 site in Turkey (Türkiye).

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 8 inclusion and 3 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: finished, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain evaluated using the Visual Analog Scale (time frame: change from baseline implamentation patent and after 0 and 1 postoperative day of practice.). 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 7 Sep 2023.

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