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NCT Number: NCT06254079

The Effect of Video-based Education on Anxiety, Pain and Recovery Quality in Patients Undergoing Laparoscopic Cholecystectomy.

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.

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Key information

Conditions

Laparoscopic Cholecystectomy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erciyes University, Kayseri, Talas, Turkey (Türkiye)

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About this study

A total of 2 patients, 1 patients in the experimental and 1 patients in the control groups, were excluded from the study because they were converted from laparoscopic surgery to open surgery.The study was completed with 70 patients (35 experimental and 35 control) who underwent laparoscopic cholecystectomy and met the inclusion criteria.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

video based education

Procedure

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.

Primary outcomes

  1. Video based education

    Time frame: 1 day

    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.

Secondary outcomes

  1. Surgical Anxiety

    Time frame: 1 day

    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.

  2. Visual Analog Scale Pain

    Time frame: up to 24 hours

    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.

  3. Recovery Quality

    Time frame: up to 24 hours

    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.

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Official study title

The Effect of Video-based Training Given by Operating Room Nurses to Patients Undergoing Laparoscopic Cholecystectomy on Anxiety, Pain and Recovery Quality.

Acronym: EDUCATION

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 12, 2024
Registry last updated
Jul 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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