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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04260334
Other study ID # 2019/06-42
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 11, 2019
Est. completion date September 30, 2020

Study information

Verified date April 2022
Source Dokuz Eylul University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A randomised controlled trial study consisting of two-group pretest-post-test.


Description:

This study was designed as a randomized controlled trial with pretest and posttest model. The sample of the research consisted of patients who would undergo ovarian cancer surgery at the gynecologic oncology unit of a university hospital in Turkey between June 2019-August 2020. The women were randomly assigned using "a random number generation program (Research Randomizer (https://www.randomizer.org/)" by an independent researcher who was not included in the study, intervention and control groups were formed. Women were not informed about the group they would be a part of. However, the groups of women were known by the researchers.


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date September 30, 2020
Est. primary completion date September 30, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - 18 years and over - women who know diagnosis - women who have not psychiatric illness - women who have preoperative period - hospitalization two days before surgery Exclusion Criteria: -

Study Design


Intervention

Other:
Preoperative Education
The first two hours after the hospitalization of the patient will be met and the aim of the study will be explained. On the same day, the patient will be given breathing and relaxation exercises and explained why it is important. On the second day after the hospitalization, the patient will be evaluated and the previous day's exercises will be repeated and leg exercises will be performed. The importance of mobilization will then be highlighted. the same day gradual relaxation exercise and surgical relaxation will be administered to the patient three times. The patient will be evaluated on the first postoperative day.

Locations

Country Name City State
Turkey Health Science University Tepecik Education and Research Hospital Izmir

Sponsors (1)

Lead Sponsor Collaborator
Dokuz Eylul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Anxiety It has been measured The State and Trait Anxiety Inventory. Form Y, its most popular version, has 20 items for assessing trait anxiety and 20 for state anxiety. State anxiety items include: "I am tense; I am worried" and "I feel calm; I feel secure." Trait anxiety items include: "I worry too much over something that really doesn't matter" and "I am content; I am a steady person." All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Scores range from 20 to 80, with higher scores correlating with greater anxiety. 3 days
Primary analgesia It has been measured visual analog scale for pain. Scores range from 0 to 10, with higher scores correlating with greater pain. 3 days
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