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The Effect of Information and Coping With Anxiety Training Given to Women Before Hysterectomy on Their Level of Anxiety

Primary Purpose

Hysterectomy, Anxiety

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Information and Coping with Anxiety Training
Sponsored by
Mersin City Research & Training Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hysterectomy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • agreeing to participate in the study,
  • being able to speak and understand Turkish,
  • being in the age group of 18-65 years,
  • being admitted to the aforementioned clinic with a planned hysterectomy surgery,
  • not having any health problems preventing the person from hearing and speaking,
  • being conscious, being oriented and cooperated,
  • not having received any training on hysterectomy before the surgery and during discharge.

Exclusion Criteria:

  • not agreeing to participate in the study,
  • not being able to speak and understand Turkish,
  • being under the age group of 18 years,
  • not being admitted to the aforementioned clinic with a planned hysterectomy surgery,
  • having any health problems preventing the person from hearing and speaking,
  • not being conscious, being oriented and cooperated,
  • having received any training on hysterectomy before the surgery and during discharge.

Sites / Locations

  • Mersin University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Information and Coping with Anxiety Training Intervention

Control

Arm Description

The intervention group received information and coping with anxiety training by an instructor.

No intervention was applied to the control group.Data were collected from the control group simultaneously with the study group.

Outcomes

Primary Outcome Measures

Anxiety was assessed using the State-Trait Anxiety Scale.
The total score obtained from both scales varies between 20 and 80. It states that 0-19 points mean no anxiety, 20-39 points mean mild, 40-59 points mean moderate, 60-79 points mean severe anxiety, and individuals with a score of 60 and above need professional help

Secondary Outcome Measures

Full Information

First Posted
June 22, 2022
Last Updated
June 28, 2022
Sponsor
Mersin City Research & Training Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05436691
Brief Title
The Effect of Information and Coping With Anxiety Training Given to Women Before Hysterectomy on Their Level of Anxiety
Official Title
The Effect of Information and Coping With Anxiety Training Given to Women Before Hysterectomy on Their Level of Anxiety: A Post-Test Randomized Controlled Experimental Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
July 15, 2018 (Actual)
Primary Completion Date
December 15, 2018 (Actual)
Study Completion Date
December 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mersin City Research & Training Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Purpose: In this study, it was aimed to determine the effect of information and coping with anxiety training given to women before they undergo hysterectomy on their anxiety levels. Design and Methods: The parallel group post-test randomized controlled experimental design was used in the study. The study sample comprised 59 women.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hysterectomy, Anxiety

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Information and Coping with Anxiety Training Intervention
Arm Type
Experimental
Arm Description
The intervention group received information and coping with anxiety training by an instructor.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention was applied to the control group.Data were collected from the control group simultaneously with the study group.
Intervention Type
Other
Intervention Name(s)
Information and Coping with Anxiety Training
Intervention Description
Informing and Coping with Anxiety Training was given to the experimental group before the operation through a prepared booklet.The information booklet about the training was created by the researchers by reviewing the current literature. The booklet provides information for patients scheduled for hysterectomy about how to cope with surgery-related anxiety. The booklet provides information on what the hysterectomy is, why it is performed, what risks it has, what should be done before, during and after the hysterectomy, what rules the patient should comply with after hysterectomy, in which cases she should present to the health institution, what changes she might experience in her social, physical, sexual and emotional life after the surgery. The booklet also provides information about discharge training and coping with anxiety.
Primary Outcome Measure Information:
Title
Anxiety was assessed using the State-Trait Anxiety Scale.
Description
The total score obtained from both scales varies between 20 and 80. It states that 0-19 points mean no anxiety, 20-39 points mean mild, 40-59 points mean moderate, 60-79 points mean severe anxiety, and individuals with a score of 60 and above need professional help
Time Frame
preoperative

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
being a woman depending on the hysterectomy surgery
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: agreeing to participate in the study, being able to speak and understand Turkish, being in the age group of 18-65 years, being admitted to the aforementioned clinic with a planned hysterectomy surgery, not having any health problems preventing the person from hearing and speaking, being conscious, being oriented and cooperated, not having received any training on hysterectomy before the surgery and during discharge. Exclusion Criteria: not agreeing to participate in the study, not being able to speak and understand Turkish, being under the age group of 18 years, not being admitted to the aforementioned clinic with a planned hysterectomy surgery, having any health problems preventing the person from hearing and speaking, not being conscious, being oriented and cooperated, having received any training on hysterectomy before the surgery and during discharge.
Facility Information:
Facility Name
Mersin University
City
Mersin
ZIP/Postal Code
33343
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Information and Coping With Anxiety Training Given to Women Before Hysterectomy on Their Level of Anxiety

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