NCT02938845

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

October 12, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 19, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 8, 2016

Status Verified

December 1, 2016

Enrollment Period

3.9 years

First QC Date

October 12, 2016

Last Update Submit

December 6, 2016

Conditions

Anxiety

Outcome Measures

Primary Outcomes (2)

  • 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.

Study Arms (2)

total laparoscopic hysterectomy(TLH)

EXPERIMENTAL

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 )Procedure: total laparoscopic hysterectomy(TLH)

total abdominal hysterectomy(TAH)

EXPERIMENTAL

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 )Procedure: total abdominal hysterectomy(TAH)

Interventions

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 abdominal hysterectomy(TAH)total laparoscopic hysterectomy(TLH)
total laparoscopic hysterectomy(TLH)PROCEDURE
total laparoscopic hysterectomy(TLH)
total abdominal hysterectomy(TAH)PROCEDURE
total abdominal hysterectomy(TAH)

Eligibility Criteria

Age35 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • undergone hysterectomies for benign reasons.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zeynep Kamil Woman and Child Diseases Education and Research Hospital

Istanbul, 34000, Turkey (Türkiye)

Location

Related Publications (3)

  • Lopez-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. Epub 2013 Jan 26.

    PMID: 23357053RESULT

  • 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.

    PMID: 18423273RESULT

  • Flory N, Bissonnette F, Binik YM. Psychosocial effects of hysterectomy: literature review. J Psychosom Res. 2005 Sep;59(3):117-29. doi: 10.1016/j.jpsychores.2005.05.009.

    PMID: 16198184RESULT

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor

Study Record Dates

First Submitted

October 12, 2016

First Posted

October 19, 2016

Study Start

January 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

December 8, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will share

Locations

TU(1)