Does Minimally Invasive Surgery Reduce Anxiety?

Not Applicable

Completed

• Conditions: Anxiety
• Interventions: Behavioral: Spielberger's State-Trait Anxiety Inventory(STAI ); Procedure: total abdominal hysterectomy(TAH); Procedure: total laparoscopic hysterectomy(TLH)

• Registration Number: NCT02938845
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2013-01
• Study First Submitted: 2016-10-12
• Study First Submitted QC: 2016-10-18
• Study First Posted: 2016-10-19
• Status Verified: 2016-12
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Last Update Submitted: 2016-12-06
• Last Update Posted: 2016-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 74

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
total abdominal hysterectomy(TAH)	Spielberger's State-Trait Anxiety Inventory(STAI )	Each patient's anxiety was measured using Spielberger's State-Trait Anxiety Inventory immediately before, immediately after the operation.
total laparoscopic hysterectomy(TLH)	Spielberger's State-Trait Anxiety Inventory(STAI )	Each patient's anxiety was measured using Spielberger's State-Trait Anxiety Inventory immediately before, immediately after the operation.
total abdominal hysterectomy(TAH)	total abdominal hysterectomy(TAH)	Each patient's anxiety was measured using Spielberger's State-Trait Anxiety Inventory immediately before, immediately after the operation.
total laparoscopic hysterectomy(TLH)	total laparoscopic hysterectomy(TLH)	Each patient's anxiety was measured using Spielberger's State-Trait Anxiety Inventory immediately before, immediately after the operation.

Primary Outcome Measures

Name	Time	Method
STAI-S's Inventory	change from immediately before operation to immediately after the operation.
STAI-T's Inventory	change from immediately before operation to immediately after the operation.

Trial Locations

Locations (1)

Zeynep Kamil Woman and Child Diseases Education and Research Hospital; 🇹🇷 Istanbul, Turkey