Preoperative Care In Ovarian Cancer Patients

NCT ID: NCT04260334

Last Updated: 2022-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-11

Study Completion Date

2020-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Adnexal Mass Perioperative Complication Outcome, Fatal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention Group

RFNP was created by researchers. RFNP comprises positive language, a positive environment, relaxation exercise and methods of coping with stress (Mete et al., 2017; Mete et al., 2015; Lazarus, 1984). This programme has a content which reducing women's anxiety and pain. Such programmes are expected to enhanced level of the knowledge about ovarian cancer and its surgery. Women are usually admitted to the clinic two days before surgery. The program duration was for 2 days each day with two sessions, of 6 hr each. There are four relaxation exercises in the program because repetition is recommended for the relaxation exercises to be effective. Deep breathing exercise, progressive muscle relaxation, and guided imagery were used in program. In addition, RFNP is divided into four sections so that the information is not intensely transferred to women.

Group Type EXPERIMENTAL

Preoperative Education

Intervention Type OTHER

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.

Control Group

In the control group, women received routine nursing care in the hospital, and data collection tools were applied at the parallel hours as the experimental group. Usual nursing care included information about visitor and meal times, nurse call button, diet, drug administration and not to leave the hospital. Relaxation exercises were not practiced to patients in usual nursing care to reduce stress and anxiety.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Dokuz Eylul University

OTHER

Sponsor Role lead

Responsible Party

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Buse Güler

Research Asisstant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Buse Güler, MSc

Role: PRINCIPAL_INVESTIGATOR

Dokuz Eylul University

Locations

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Health Science University Tepecik Education and Research Hospital

Izmir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2019/06-42

Identifier Type: -

Identifier Source: org_study_id

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