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Completed

NCT Number: NCT02938845

Does Minimally Invasive Surgery Reduce Anxiety?

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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Age range

35 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Zeynep Kamil Woman and Child Diseases Education and Research Hospital

Istanbul, 34000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spielberger's State-Trait Anxiety Inventory(STAI )

Behavioral

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.

total laparoscopic hysterectomy(TLH)

Procedure

total abdominal hysterectomy(TAH)

Procedure

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Other

Registry information

Official study title

Factors Related to Patients' Anxiety Before and After Hysterectomy

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Oct 19, 2016
Registry last updated
Dec 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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