Back to resultsPreoperative Care In Ovarian Cancer Patients
Primary Purpose
Adnexal Mass, Perioperative Complication, Outcome, Fatal
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Preoperative Education
Sponsored by
About this trial
This is an interventional supportive care trial for Adnexal Mass focused on measuring Adnexal mass, Preoperative education, Anxiety
Eligibility Criteria
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:
-
Sites / Locations
- Health Science University Tepecik Education and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Group
Control Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
analgesia
It has been measured visual analog scale for pain. Scores range from 0 to 10, with higher scores correlating with greater pain.
Secondary Outcome Measures
Full Information
NCT ID
NCT04260334
First Posted
November 6, 2019
Last Updated
April 22, 2022
Sponsor
Dokuz Eylul University
1. Study Identification
Unique Protocol Identification Number
NCT04260334
Brief Title
Preoperative Care In Ovarian Cancer Patients
Official Title
Preoperative Care in Ovarian Cancer: Effects of Relaxation-Focused Nursing Program in Women With Ovarian Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
November 11, 2019 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adnexal Mass, Perioperative Complication, Outcome, Fatal
Keywords
Adnexal mass, Preoperative education, Anxiety
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Preoperative Education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Anxiety
Description
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.
Time Frame
3 days
Title
analgesia
Description
It has been measured visual analog scale for pain. Scores range from 0 to 10, with higher scores correlating with greater pain.
Time Frame
3 days
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Buse Güler, MSc
Organizational Affiliation
Dokuz Eylul University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health Science University Tepecik Education and Research Hospital
City
İzmir
ZIP/Postal Code
35100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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Preoperative Care In Ovarian Cancer Patients
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