Does Minimally Invasive Surgery Reduce Anxiety?

December 6, 2016 updated by: Ahmet Eser, Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Factors Related to Patients' Anxiety Before and After Hysterectomy

The purpose of this study was to identify factors that may contribute to anxiety of patients undergoing total abdominal hysterectomy(TAH) or total laparoscopic hysterectomy(TLH) before and after the operation. Thus, we aimed to learn whether anxiety levels change according to the type of hysterectomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hysterectomy is the most common gynecological procedure worldwide. . There has been a increasing interest towards to more minimally invasive procedures in the past decade. Hysterectomy operation anxiety is a complex phenomenon affected by various parameters. Patients' anxiety may be affected by their age, gender, educational status,type of operation and personality. Each patient's anxiety was measured using Spielberger's State-Trait Anxiety Inventory immediately before, immediately after the operation.

Study Type

Interventional

Enrollment (Actual)

74

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

  • Turkey
      • Istanbul, Turkey, 34000
        • Zeynep Kamil Woman and Child Diseases Education and Research Hospital

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

35 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

undergone hysterectomies for benign reasons.

Exclusion Criteria:

malignancy, additional operation beside hysterectomy( such as salpingo-oophorectomy), history of two or more previous caesarean sections, history of previous abdominal surgery, autoimmune disease, coagulation disorders, with known systemic or psychiatric disease, those receiving any regular sedative medication at the time of the procedure

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: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: total laparoscopic hysterectomy(TLH)
Each patient's anxiety was measured using Spielberger's State-Trait Anxiety Inventory immediately before, immediately after the operation.
Behavioral: Spielberger's State-Trait Anxiety Inventory(STAI )
State anxiety (STAI-S) refers to a temporary emotional state related to a specific situation, whereas trait anxiety (STAI-T) represents anxiety as a relatively stable personality character. Each scale has values ranging from 20 to 80, with higher scores representing more severe anxiety. The STAI has no established categories, but a cutoff score of 40 has been used to identify patients with high/very high anxiety. The validity and reliability of the Turkish versions of these instruments have been validated.
Procedure: total laparoscopic hysterectomy(TLH)
EXPERIMENTAL: total abdominal hysterectomy(TAH)
Each patient's anxiety was measured using Spielberger's State-Trait Anxiety Inventory immediately before, immediately after the operation.
Behavioral: Spielberger's State-Trait Anxiety Inventory(STAI )
State anxiety (STAI-S) refers to a temporary emotional state related to a specific situation, whereas trait anxiety (STAI-T) represents anxiety as a relatively stable personality character. Each scale has values ranging from 20 to 80, with higher scores representing more severe anxiety. The STAI has no established categories, but a cutoff score of 40 has been used to identify patients with high/very high anxiety. The validity and reliability of the Turkish versions of these instruments have been validated.
Procedure: total abdominal hysterectomy(TAH)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
STAI-S's Inventory
Time Frame: change from immediately before operation to immediately after the operation.
change from immediately before operation to immediately after the operation.
STAI-T's Inventory
Time Frame: change from immediately before operation to immediately after the operation.
change from immediately before operation to immediately after the operation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2013

Primary Completion (ACTUAL)

December 1, 2016

Study Completion (ACTUAL)

December 1, 2016

Study Registration Dates

First Submitted

October 12, 2016

First Submitted That Met QC Criteria

October 18, 2016

First Posted (ESTIMATE)

October 19, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

December 8, 2016

Last Update Submitted That Met QC Criteria

December 6, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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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