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Does Minimally Invasive Surgery Reduce Anxiety?

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ClinicalTrials.gov Identifier: NCT02938845
Recruitment Status : Completed
First Posted : October 19, 2016
Last Update Posted : December 8, 2016
Sponsor:
Information provided by (Responsible Party):
Ahmet Eser, Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Anxiety Behavioral: Spielberger's State-Trait Anxiety Inventory(STAI ) Procedure: total laparoscopic hysterectomy(TLH) Procedure: total abdominal hysterectomy(TAH) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Factors Related to Patients' Anxiety Before and After Hysterectomy
Study Start Date : January 2013
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Hysterectomy

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)



Primary Outcome Measures :
  1. STAI-S's Inventory [ Time Frame: change from immediately before operation to immediately after the operation. ]
  2. STAI-T's Inventory [ Time Frame: change from immediately before operation to immediately after the operation. ]


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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02938845


Locations
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Turkey
Zeynep Kamil Woman and Child Diseases Education and Research Hospital
Istanbul, Turkey, 34000
Sponsors and Collaborators
Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Publications of Results:
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Responsible Party: Ahmet Eser, medical doctor, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
ClinicalTrials.gov Identifier: NCT02938845     History of Changes
Other Study ID Numbers: 025
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: December 8, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders