Preoperative Care In Ovarian Cancer Patients

NCT04260334 | Completed DMC

• 1 other identifier: 2019/06-42
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Adnexal Mass; Perioperative Complication; Outcome, Fatal

Keywords

Adnexal mass; Preoperative education; Anxiety

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Other: Preoperative Education

Control Group

NO INTERVENTION

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.

Interventions

Preoperative Education 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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and over
• women who know diagnosis
• women who have not psychiatric illness
• women who have preoperative period
• hospitalization two days before surgery

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Health Science University Tepecik Education and Research Hospital

Izmir, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Buse Güler, MSc

  Dokuz Eylul University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Asisstant

Study Record Dates

• First Submitted: November 6, 2019
• First Posted: February 7, 2020
• Study Start: November 11, 2019
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: April 29, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)