NCT06254079

Brief Summary

The reasons for anxiety before laparoscopic cholecystectomy include the operation of the surgery process, its therapeutic effect, lack of information about the postoperative period and lack of communication. The increase in the preoperative anxiety level in patients undergoing surgical intervention negatively affects the patients\' sleep, recovery and quality of life, length of hospital stay is prolonged, cost increases in hospitals, and socioeconomic losses occur in individuals and institutions. Therefore, this study will be conducted as a randomized controlled experimental study to determine the effect of video-based training given by an operating room nurse to patients undergoing laparoscopic cholecystectomy on preoperative anxiety, postoperative pain and recovery quality. Considering possible sample loss, it was decided to include 72 patients, 36 in the intervention group and 36 in the control group. One of the patients included in both the intervention and control groups was excluded from the study because he was converted to open cholecystectomy during surgery and was taken to intensive care postoperatively. The study was completed with a total of 70 patients, 35 in the intervention group and 35 in the control group. Patient Information Form, Surgical Anxiety Scale, Visual Analogue Scale (VAS) and Recovery Quality Scale-15 will be used to collect data.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

2 active sites

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

March 1, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 12, 2024

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

July 24, 2024

Status Verified

July 1, 2024

Enrollment Period

1 year

First QC Date

January 31, 2024

Last Update Submit

July 22, 2024

Conditions

Keywords

Video-based educationOperating room nurseLaparoscopic Cholecystectomy

Outcome Measures

Primary Outcomes (1)

  • Video based education

    The video includes information about various aspects such as preoperative waiting and postoperative recovery units, the operating room, tables with surgical instruments, sterile drapes, and characteristics of surgical team members. Additionally, details are provided regarding the information to be obtained from patients upon arrival in the operating room, positions to be instructed for the surgical procedure and corresponding precautions, communication methods with the patient's family during the surgery, interventions in the postoperative recovery unit, and criteria for transferring patients to the regular service after surgery.

    1 day

Secondary Outcomes (3)

  • Surgical Anxiety

    1 day

  • Visual Analog Scale Pain

    up to 24 hours

  • Recovery Quality

    up to 24 hours

Study Arms (2)

Intervention group

EXPERIMENTAL

A video containing information about the operating room environment and intraoperative care will be watched. The patients who watch the video will be questioned again about the points they do not understand, the issues they are curious about about the perioperative period, and the information they want to learn, and this information will be given verbally by the researchers.

Procedure: video based education

Control Group

NO INTERVENTION

Patients in this group will not be shown any videos and will continue to receive care according to their clinical routine.They will be asked to answer the questions in the patient introduction form the day before the surgical intervention. The surgical anxiety scale will be filled in when patients come from the ward to the preoperative waiting room on the day of surgery. Finally, patients will be asked to answer the questions on VAS and Quality of Recovery-15 (QoR-15) in the patient room at the 24th hour after surgery.

Interventions

The patients in the experimental group will be shown a video containing information about the operating room environment and care during surgery. The video content includes the following details: the operating room temperature being maintained at 18-24°C; the patient being placed on the operating table by the staff in the presence of an anesthesia technician; the establishment of intravenous access by the anesthesia technician; monitoring of blood pressure, pulse, respiration, and EKG indicators; the insertion of a urinary catheter by the surgical nurse after the patient is anesthetized; post-awakening transfer to the postoperative recovery unit with the anesthesia technician and personnel; reception and monitoring of vital signs, pain assessment, intervention, and observation for a period by a nurse in this unit; and finally, transfer to the General Surgery Service.

Intervention group

Eligibility Criteria

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

You may qualify if:

  • Agreeing to participate in the research,
  • Knows how to read, write and speak Turkish,
  • Patients who will undergo elective laparoscopic cholecystectomy in the General Surgery Service will be included.

You may not qualify if:

  • Have cognitive, auditory and psychological problems that may affect communication with researchers,
  • Using psychiatric medication,
  • Undergoing surgical intervention under emergency conditions,
  • Subjected to spinal, epidural or local anesthesia during surge

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Erciyes University

Kayseri, Talas, 38080, Turkey (Türkiye)

Location

Erciyes University

Kayseri, 38080, Turkey (Türkiye)

Location

Related Publications (3)

  • Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.

  • Dolan R, Huh J, Tiwari N, Sproat T, Camilleri-Brennan J. A prospective analysis of sleep deprivation and disturbance in surgical patients. Ann Med Surg (Lond). 2016 Jan 6;6:1-5. doi: 10.1016/j.amsu.2015.12.046. eCollection 2016 Mar.

  • Gursoy A, Candas B, Guner S, Yilmaz S. Preoperative Stress: An Operating Room Nurse Intervention Assessment. J Perianesth Nurs. 2016 Dec;31(6):495-503. doi: 10.1016/j.jopan.2015.08.011. Epub 2016 May 6.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: designed as a randomized controlled experimental
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Assoc.Prof. Dr

Study Record Dates

First Submitted

January 31, 2024

First Posted

February 12, 2024

Study Start

March 1, 2023

Primary Completion

March 1, 2024

Study Completion

March 1, 2024

Last Updated

July 24, 2024

Record last verified: 2024-07

Locations