- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05436691
The Effect of Information and Coping With Anxiety Training Given to Women Before Hysterectomy on Their Level of Anxiety
March 20, 2024 updated by: Elcin Alacam, Mersin Training and Research Hospital
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
59
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Mersin, Turkey, 33343
- Mersin University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Information and Coping with Anxiety Training Intervention
The intervention group received information and coping with anxiety training by an instructor.
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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.
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No Intervention: Control
No intervention was applied to the control group.Data were collected from the control group simultaneously with the study group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Anxiety was assessed using the State-Trait Anxiety Scale.
Time Frame: preoperative
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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
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preoperative
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 15, 2018
Primary Completion (Actual)
December 15, 2018
Study Completion (Actual)
December 15, 2018
Study Registration Dates
First Submitted
June 22, 2022
First Submitted That Met QC Criteria
June 28, 2022
First Posted (Actual)
June 29, 2022
Study Record Updates
Last Update Posted (Actual)
March 21, 2024
Last Update Submitted That Met QC Criteria
March 20, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MersinCity
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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