NCT05436691

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2018

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

June 22, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 29, 2022

Completed
Last Updated

March 21, 2024

Status Verified

March 1, 2024

Enrollment Period

5 months

First QC Date

June 22, 2022

Last Update Submit

March 20, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    preoperative

Study Arms (2)

Information and Coping with Anxiety Training Intervention

EXPERIMENTAL

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

Other: Information and Coping with Anxiety Training

Control

NO INTERVENTION

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

Interventions

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.

Information and Coping with Anxiety Training Intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsbeing a woman depending on the hysterectomy surgery
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mersin University

Mersin, 33343, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Coping Skills

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc, Nurse, Principal Investigator

Study Record Dates

First Submitted

June 22, 2022

First Posted

June 29, 2022

Study Start

July 15, 2018

Primary Completion

December 15, 2018

Study Completion

December 15, 2018

Last Updated

March 21, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations