Does Minimally Invasive Surgery Reduce Anxiety?

Anxiety Clinical Trial

Official title:

Factors Related to Patients' Anxiety Before and After Hysterectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02938845
• Other study ID #: 025
• Status: Completed
• Phase: N/A
• First received: October 12, 2016
• Last updated: December 6, 2016
• Start date: January 2013
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 70 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

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)

• total abdominal hysterectomy(TAH)

Locations

Country	Name	City	State
Turkey	Zeynep Kamil Woman and Child Diseases Education and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Flory N, Bissonnette F, Binik YM. Psychosocial effects of hysterectomy: literature review. J Psychosom Res. 2005 Sep;59(3):117-29. Review. — View Citation

López-Jornet P, Camacho-Alonso F, Sanchez-Siles M. Assessment of general pre and postoperative anxiety in patients undergoing tooth extraction: a prospective study. Br J Oral Maxillofac Surg. 2014 Jan;52(1):18-23. doi: 10.1016/j.bjoms.2013.01.004. — View Citation

Muglali M, Komerik N. Factors related to patients' anxiety before and after oral surgery. J Oral Maxillofac Surg. 2008 May;66(5):870-7. doi: 10.1016/j.joms.2007.06.662. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	STAI-S's Inventory		change from immediately before operation to immediately after the operation.	No
Primary	STAI-T's Inventory		change from immediately before operation to immediately after the operation.	No