Laparoscopic CholecystectomyEDUCATIONNCT06254079
The Effect of Video-based Education on Anxiety, Pain and Recovery Quality in Patients Undergoing Laparoscopic Cholecystectomy.
A study testing video based education in people with Laparoscopic Cholecystectomy, run by TC Erciyes University at 2 sites in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Laparoscopic Cholecystectomy
- What is being tested?
- video based education
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Mar 2023to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Erciyes University
Kayseri, Talas, 38080
Erciyes University
Kayseri, 38080
About this study
Official title: The Effect of Video-based Training Given by Operating Room Nurses to Patients Undergoing Laparoscopic Cholecystectomy on Anxiety, Pain and Recovery Quality.
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.
Read the detailed description
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.
- Conditions
- Laparoscopic Cholecystectomy
- Being tested
- video based education
- Keywords
- Video-based education, Operating room nurse, Laparoscopic Cholecystectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
video based educationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (3)
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.
Measured: 1 day
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.
Measured: up to 24 hours
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.
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start1 Mar 2023
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic CholecystectomyStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- designed as a randomized controlled experimental
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yeliz Sürme, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06254079
- Sponsor's protocol ID
- 2023/46
- Acronym
- EDUCATION
- Status last verified
- Jul 2024
- First submitted
- 31 Jan 2024
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 23411725Dolan 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.
PubMed 26909151Gursoy 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.
PubMed 27931701
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Video-based Training Given by Operating Room Nurses to Patients Undergoing Laparoscopic Cholecystectomy on Anxiety, Pain and Recovery Quality.
- ClinicalTrials.gov ID
- NCT06254079
- Acronym / sponsor ID
- EDUCATION / 2023/46
- Conditions
- Laparoscopic Cholecystectomy
- Keywords
- Video-based education, Operating room nurse, Laparoscopic Cholecystectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 12 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- designed as a randomized controlled experimental
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Procedure: video based educationA 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 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Agreeing to participate in the research,
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| video based educationThe 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. | Procedure or surgery | Intervention group |
Primary outcome
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.
3 secondary outcomes
Surgical Anxiety
Time frame: 1 day
Visual Analog Scale Pain
Time frame: up to 24 hours
Recovery Quality
Time frame: up to 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- Results publication: PubMed 23411725Stark 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.
- Results publication: PubMed 26909151Dolan 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.
- Results publication: PubMed 27931701Gursoy 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing video based education in people with Laparoscopic Cholecystectomy, run by TC Erciyes University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Video based education (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06254079, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.