NCT05359458

Brief Summary

Aim: In this study, the effect of Emotional Freedom Technique applied to patients before Laparoscopic Cholecystectomy on surgical fear and anxiety was investigated. Design: This is a randomized controlled study. Method: A total of 112 patients who were going to have Laparoscopic Cholecystectomy were randomly divided into two groups each including 56 participants. The intervention group was provided with Emotional Freedom Technique. The control group received routine face-to-face education. Surgical fear and anxiety were examined.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 3, 2022

Completed
Last Updated

May 3, 2022

Status Verified

April 1, 2022

Enrollment Period

5 months

First QC Date

April 11, 2022

Last Update Submit

April 29, 2022

Conditions

Keywords

surgeryanxiety

Outcome Measures

Primary Outcomes (1)

  • Surgical Fear Scale

    Surgical Fear Scale will be filled in the preoperative period. ll items are scored on an eleven point numeric rating scale (NRS) ranging from 0 (not at all afraid) to 10 (very afraid). This results in a score of 0-40 for each subscale and a total score of 0 to 80.

    through study completion, an average of 5 month

Secondary Outcomes (1)

  • Anxiety Scale

    through study completion, an average of 5 month

Study Arms (2)

Emotional Freedom Liberation Technique Applied to Laparoscopic Cholecystectomy Patients

EXPERIMENTAL

The intervention group is the group in which the investigators applied Emotional Freedom Liberation Technique Intervention: Behavioral: Emotional Freedom Liberation Technique

Behavioral: Emotional Freedom Liberation Technique

Standard Clinical Care Applied to Laparoscopic Cholecystectomy Patients

NO INTERVENTION

The control group is the group that receives standard clinical care

Interventions

The investigators will apply Emotional Freedom Liberation Technique

Emotional Freedom Liberation Technique Applied to Laparoscopic Cholecystectomy Patients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical treatment for Laparoscopic Cholecystectomy
  • years of age or older
  • Mentally healthy

You may not qualify if:

  • Agree to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University

Erzurum, ABD Veya Kanada'da Lütfen Seçin ..., 25070, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asistant Professors

Study Record Dates

First Submitted

April 11, 2022

First Posted

May 3, 2022

Study Start

August 1, 2021

Primary Completion

January 1, 2022

Study Completion

January 30, 2022

Last Updated

May 3, 2022

Record last verified: 2022-04

Locations