The Effect of Video-based Education on Anxiety, Pain and Recovery Quality in Patients Undergoing Laparoscopic Cholecystectomy.
EDUCATION
The Effect of Video-based Training Given by Operating Room Nurses to Patients Undergoing Laparoscopic Cholecystectomy on Anxiety, Pain and Recovery Quality.
1 other identifier
interventional
70
1 country
2
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2023
2 active sites
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
March 1, 2023
CompletedFirst Submitted
Initial submission to the registry
January 31, 2024
CompletedFirst Posted
Study publicly available on registry
February 12, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2024
CompletedJuly 24, 2024
July 1, 2024
1 year
January 31, 2024
July 22, 2024
Conditions
Keywords
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
EXPERIMENTALA 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.
Control Group
NO INTERVENTIONPatients 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.
Eligibility Criteria
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)
Erciyes University
Kayseri, 38080, Turkey (Türkiye)
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.
PMID: 23411725RESULTDolan 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.
PMID: 26909151RESULTGursoy 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.
PMID: 27931701RESULT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- 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