Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06254079
Other study ID # 2023/46
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 1, 2023
Est. completion date June 1, 2024

Study information

Verified date February 2024
Source TC Erciyes University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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. 46 patients (23 experimental, 23 control group) who underwent laparoscopic cholecystectomy will be included in the study.Patient Information Form, Surgical Anxiety Scale, Visual Analogue Scale (VAS) and Recovery Quality Scale-15 will be used to collect data.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 46
Est. completion date June 1, 2024
Est. primary completion date April 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
video based education
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.

Locations

Country Name City State
Turkey Erciyes University Kayseri Talas
Turkey Erciyes University Kayseri

Sponsors (1)

Lead Sponsor Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Surgical Anxiety The surgical anxiety scale will be filled out when patients come from the ward to the preoperative waiting room on the day of surgery.Scores between 0 and 60 are taken from the scale. As the score obtained from the scale increases, the individual's anxiety is interpreted as high. 1 day
Secondary Visual Analog Scale Pain Application of visual analog scale pain to all patients at the 24 hours later after surgery. The range of scores on the scale varies between 0-10, and higher scores indicate increased pain intensity. up to 24 hours
Secondary Recovery Quality The Quality of Healing-15 Scale was completed by all patients 24 hours later after the surgery.The score range that can be obtained from the scale varies between 0-150. As the score increases, the quality of recovery increases. up to 24 hours
See also
  Status Clinical Trial Phase
Completed NCT03670849 - Image Fusion in the OR N/A
Withdrawn NCT04561583 - Effectiveness and Safety of LED Light Source System for Endoscope N/A
Completed NCT00872287 - Pain in Single Incision Laparoscopic Surgery Cholecystectomy Phase 4
Recruiting NCT06017167 - Prophylaxis Against Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy Phase 2
Completed NCT05536557 - Bilateral External Oblique Ä°ntercostal (EOI) Plane Block in Patients Undergoing Laparoscopic Cholecystectomy. N/A
Recruiting NCT05794503 - Postoperative Urinary Retention After Reversal of Neuromuscular Block by Neostigmine Versus Sugammadex Early Phase 1
Completed NCT05998317 - Dexamethasone at Night vs at Induction on PONV After Laparoscopic Cholecystectomy Phase 2/Phase 3
Completed NCT04759079 - The Effects of Acupuncture Against Postoperative Nausea and Vomit After Laparoscopic Cholecystectomy N/A
Recruiting NCT04138472 - Comparison Of Dexmedetomidine, Fentanyl And Lignocaine In Attenuation Of Hemodynamic Response To Direct Laryngoscopy And Intubation In Patient Undergoing Laparoscopic Cholecystectomy N/A
Recruiting NCT06022926 - Investigation of the Intraoperative and Postoperative Effects of Warming Patients in Laparoscopic Cholecystectomy N/A
Completed NCT02469831 - Respiratory Mechanics and Metabolic Changes During Low Pressure Laparoscopic Cholecystectomy Phase 2
Completed NCT03067038 - Single Incision Versus Three Port Laparoscopic Cholecystectomy N/A
Completed NCT00886210 - Clinical Impact of Routine Abdominal Drainage After Laparoscopic Cholecystectomy N/A
Completed NCT00292214 - Comparing Intravenous and Oral Paracetamol for Cholecystectomy Phase 4
Recruiting NCT05533580 - Differential Effects of Remimazolam and Propofol on Dynamic Cerebral Autoregulation During General Anesthesia N/A
Recruiting NCT05533567 - Electroencephalographic Profiles During General Anesthesia: a Comparative Study of Remimazolam and Propofol N/A
Active, not recruiting NCT05636475 - The Effect Of Machine-Based And Manually Applied Hand Massage On Pain, Anxiety And Gastrointestinal System Functions After Laparoscopic Cholecystectomy Surgery N/A
Recruiting NCT05094193 - Trocar-site Infiltration Versus TAP-block N/A
Completed NCT03323684 - Quadratus Lumborum Block vs Transversus Abdominis Plane Block for Post-cholecystectomy Analgesia N/A
Recruiting NCT04162106 - Feasibility of the Ultravision™ System in Low Pressure Laparoscopic Cholecystectomy Compared to Airseal® IFS N/A