Preoperative Care In Ovarian Cancer Patients

Not Applicable

Completed

• Conditions: Adnexal Mass; Outcome, Fatal; Perioperative Complication
• Interventions: Other: Preoperative Education

• Registration Number: NCT04260334
• Lead Sponsor: Dokuz Eylul University

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2019-11-06
• Study Start: 2019-11-11
• Study First Submitted QC: 2020-02-05
• Study First Posted: 2020-02-07
• Primary Completion: 2020-09-30
• Study Completion: 2020-09-30
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-22
• Last Update Posted: 2022-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 46

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Preoperative Education	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.

Primary Outcome Measures

Name	Time	Method
Anxiety	3 days	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.
analgesia	3 days	It has been measured visual analog scale for pain. Scores range from 0 to 10, with higher scores correlating with greater pain.

Trial Locations

Locations (1)

Health Science University Tepecik Education and Research Hospital; 🇹🇷 İzmir, Turkey