Laparoscopic CholecystectomyOSHNCT06511271
Osmaniye State Hospital"
A study testing relaxation exercises in people with Laparoscopic Cholecystectomy, run by Osmaniye Korkut Ata University at 1 site in Turkey (Türkiye).
Trial summary
Objective: It was conducted as a randomized controlled experimental study to determine the effect of progressive relaxation exercise applied after laparoscopic cholecystectomy on postoperative pain, nausea and vomiting. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Laparoscopic Cholecystectomy
- What is being tested?
- relaxation exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 May 2023to 25 Aug 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- *To participate in the research willing
- Prevents exercise creating a chronic without disease (COPD, heart failure etc.)
- Hearing problem not found
- At least primary school graduate the one which...
- A psychiatric diagnosis non-major depression, anxiety disorders etc.) and anxiety or a drug for depression non-user
- Elective laparoscopic having a cholecystectomy
- Oriented to person, place and time the one which...
- American Anesthesia Association(ASA) classification I, II or III the one which...
Who cannot join
- Under 18 and over 70 patients over (n=2)
- Agree to participate in the research not (n=12)
- Patients undergoing emergency surgery
- Prevents exercise with disease causing
- Hearing problem found
- Having a psychiatric diagnosis (major depression, anxiety disorders etc.) and anxiety or a depression taking medication
Show all 13Show fewer
- Pregnant
- Suffering from motion sickness
- Lack of cooperation
- Basic during surgery in life functions developing complications
- Open cholecystectomy (n=2)
- American Society of Anesthesiologists (ASA) classification IV are(n=7)
- Previous PGE exercises educated
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Osmaniye State Hospital
Center, Osmani̇ye, 80010
About this study
Official title: Effect of Progressive Relaxations Applied After Laparoscopic Cholecystectomy on Pain, Nausea and Vomiting
Objective: It was conducted as a randomized controlled experimental study to determine the effect of progressive relaxation exercise applied after laparoscopic cholecystectomy on postoperative pain, nausea and vomiting. Method: The population of the study consisted of 105 patients who underwent elective planned laparoscopic cholecystectomy at Osmaniye State Hospital General Surgery Clinic between 25 May and 25 August 2023(Study=38, Control=38). 76 patients, who constituted the sample of the study, were assigned to the study and control groups. Data were collected using the Patient Introduction Form Visual Comparison Scale and Perioperative Patient Monitoring Form.
Patients in the study group underwent progressive relaxation exercises at the 2nd, 6th, 12th and 24th hours after surgery. Frequency, average, Chi-Square test, Independent t-test and Repeated Measures ANOVA test were used to evaluate the data. Results: When the comparison between groups is examined; It was determined that the average pain intensity scores of the patients in the study group at the 6th, 12th and 24th postoperative hours decreased more than the control group and the difference between them was statistically significant (p\<0.05). When the comparison between groups is examined; It was determined that the average nausea severity scores of the patients in the study group at the 6th, 12th and 24th postoperative hours decreased significantly compared to the control group and the difference between them was statistically significant (p\<0.05). It was determined that there was a decrease in vomiting rates in the study group compared to the control group at the 6th and 12th hours after surgery and the difference between them was significant. Conclusion and Recommendations: It has been determined that progressive relaxation exercises reduces pain, nausea and vomiting after laparoscopic cholecystectomy. In line with the results obtained from the research, it is recommended that nurses teach progressive relaxation exercises to patients and encourage their use, as they are easy to apply to patients and are not an invasive method. Keywords: Laparoscopic cholecystectomy, nausea, nurse, pain, progressive relaxation exercises.
Read the detailed description
Data were collected at Osmaniye State Hospital General Surgery Clinic between 25 May and 25 August 2023.
Among 76 patients who were hospitalized for laparoscopic cholecystectomy and volunteered to participate in the study (Study group = 38, Control group = 38) was taken. Before starting the application, ;Informed Voluntary ; was obtained from the patients.
Verbal and written permissions were obtained by reading the ; (Annex-I). Working group - Before the patient undergoes surgery, the Patient Information Form (Annex-II) information is obtained from the patient file and asked to the patient.
has been filled.
- The researcher was informed about the surgical intervention, expected nausea and vomiting, and pain.
- The first 10-minute part of the CD audio recordings prepared by the Turkish Psychologists Association is about deep relaxation. purpose; The second 30-minute part includes instructions for relaxation exercises; The last 30 minutes are just it consists of relaxation music.
- In addition to standard treatment and care for laparoscopic cholecystectomy, volunteers who accept the study Progressive relaxation exercises were applied by the researcher at the 2nd, 6th, 12th and 24th hours after surgery.
When the literature review on PGE was made, it was seen that the application time and frequency of these exercises were not standard; 6th, 12th, 24th hours after surgery; It was applied on the 2nd day after surgery and the total number of sessions varied.
It is seen to show . In our study, PGE was detected at the 2nd, 6th, 12th and 24th hours after surgery.
has been implemented.Control group patients were informed about the research and received Informed Voluntary Consent Form (ANNEX-I) verbal and written permissions were obtained. - Before the surgery, the Patient Introduction Form (Annex-II) was checked both from the file and received verbal confirmation from the patient.
was filled in.
- The researcher was informed about the surgical intervention, expected nausea and vomiting, and pain.
- Patients in the control group were given the standard procedure for laparoscopic cholecystectomy only during the research period. treatment and care were applied.
- No postoperative intervention was performed on the control group, and the researcher did not perform surgery after surgery.
Visual Comparison Scale (ANNEX-III) form for the severity of pain, nausea and vomiting at the 2nd, 6th, 12th and 24th hours The patient is asked to mark it with a pen or verbally indicate the severity between 1 and 10 on the form.
marking has been made.
- After the postoperative pain, nausea and vomiting status is determined on the Visual Comparison Scale, perioperative Patient Follow-up Form (ANNEX-IV) has been filled out.
- Data collection process of the research in order to eliminate ethical problems that may occur in the control group After completion, these patients were trained in progressive relaxation exercises.
- Conditions
- Laparoscopic Cholecystectomy
- Being tested
- relaxation exercises
- Keywords
- laparoscopic cholecystectomy, Postoperative Pain, nausea, vomiting
- Medical subject headings
- Pain, Postoperative, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
relaxation exercisesOther
The first 10-minute part of the CD audio recordings prepared by the Turkish Psychologists Association is about deep relaxation.
purpose; The second 30-minute part includes instructions for relaxation exercises; The last 30 minutes are just consists of relaxation music
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | No intervention | Patients in the control group were given only the standard procedure for laparoscopic cholecystectomy during the research period. treatment and care were applied. |
| Group 2 | Experimental | The first 10-minute part of the CD audio recordings prepared by the Turkish Psychologists Association is about deep relaxation. purpose; The second 30-minute part includes instructions for relaxation exercises; The last 30 minutes are just It consists of relaxation music[145]. In our study, the instructions in the second part were used. - In addition to standard treatment and care for laparoscopic cholecystectomy, volunteers who accept the study Progressive relaxation exercises were applied by the researcher at the 2nd, 6th, 12th and 24th hours after surgery. When the literature review on PGE was made, it was seen that the application time and frequency of these exercises were not standard; 6th, 12th, 24th hours after surgery; It was applied on the 2nd day after surgery and the total number of sessions varied. It is seen to show. In our study, PGE was detected at the 2nd, 6t Receives: Other: relaxation exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain, nausea and vomiting 1
The severity of pain, nausea, and vomiting was assessed by the researcher at the 2nd hour using a visual analog scale.
Measured: at the 2nd hour after surgery
Secondary outcomes (3)
pain, nausea and vomiting 2
he severity of pain, nausea, and vomiting was assessed by the researcher at the 6th hour using a visual analog scale. vomiting at the 6th hours after surgery.
Measured: at the 6nd hours after surgery
pain, nausea and vomiting 3
The severity of pain, nausea, and vomiting was assessed by the researcher at the 12 thhour using a visual analog scale.
Measured: at the 12th hour after surgery
pain, nausea and vomiting 4
The severity of pain, nausea, and vomiting was assessed by the researcher at the 24th hour using a visual analog scale.
Measured: at the 24th hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start25 May 2023
- Primary completion25 Aug 2023
- Study completion25 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic CholecystectomyStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients in the study group underwent progressive relaxation exercises at the 2nd, 6th, 12th and 24th hours after surgery
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osmaniye Korkut Ata University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Songul Gungor, Osmaniye Korkut Ata University
- Investigators
- Didem LAFÇI, associate professor, Study director, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06511271
- Sponsor's protocol ID
- Osmaniye State Hospital"
- Acronym
- OSH
- Status last verified
- Jul 2024
- First submitted
- 28 May 2024
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no ipd
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Progressive Relaxations Applied After Laparoscopic Cholecystectomy on Pain, Nausea and Vomiting
- ClinicalTrials.gov ID
- NCT06511271
- Acronym / sponsor ID
- OSH / Osmaniye State Hospital"
- Conditions
- Laparoscopic Cholecystectomy
- Keywords
- laparoscopic cholecystectomy, Postoperative Pain, nausea, vomiting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Osmaniye Korkut Ata UniversityUniversity, hospital or other
- Study start
- 25 May 2023 (actual)
- Primary completion
- 25 Aug 2023 (actual)
- Study completion
- 25 Aug 2023 (actual)
- First posted
- 19 Jul 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.
Objective: It was conducted as a randomized controlled experimental study to determine the effect of progressive relaxation exercise applied after laparoscopic cholecystectomy on postoperative pain, nausea and vomiting. Method: The population of the study consisted of 105 patients who underwent elective planned laparoscopic cholecystectomy at Osmaniye State Hospital General Surgery Clinic between 25 May and 25 August 2023(Study=38, Control=38). 76 patients, who constituted the sample of the study, were assigned to the study and control groups. Data were collected using the Patient Introduction Form Visual Comparison Scale and Perioperative Patient Monitoring Form.
Patients in the study group underwent progressive relaxation exercises at the 2nd, 6th, 12th and 24th hours after surgery. Frequency, average, Chi-Square test, Independent t-test and Repeated Measures ANOVA test were used to evaluate the data. Results: When the comparison between groups is examined; It was determined that the average pain intensity scores of the patients in the study group at the 6th, 12th and 24th postoperative hours decreased more than the control group and the difference between them was statistically significant (p\<0.05). When the comparison between groups is examined; It was determined that the average nausea severity scores of the patients in the study group at the 6th, 12th and 24th postoperative hours decreased significantly compared to the control group and the difference between them was statistically significant (p\<0.05). It was determined that there was a decrease in vomiting rates in the study group compared to the control group at the 6th and 12th hours after surgery and the difference between them was significant. Conclusion and Recommendations: It has been determined that progressive relaxation exercises reduces pain, nausea and vomiting after laparoscopic cholecystectomy. In line with the results obtained from the research, it is recommended that nurses teach progressive relaxation exercises to patients and encourage their use, as they are easy to apply to patients and are not an invasive method. Keywords: Laparoscopic cholecystectomy, nausea, nurse, pain, progressive relaxation exercises.
Detailed description
Data were collected at Osmaniye State Hospital General Surgery Clinic between 25 May and 25 August 2023.
Among 76 patients who were hospitalized for laparoscopic cholecystectomy and volunteered to participate in the study (Study group = 38, Control group = 38) was taken. Before starting the application, ;Informed Voluntary ; was obtained from the patients.
Verbal and written permissions were obtained by reading the ; (Annex-I). Working group - Before the patient undergoes surgery, the Patient Information Form (Annex-II) information is obtained from the patient file and asked to the patient.
has been filled.
- The researcher was informed about the surgical intervention, expected nausea and vomiting, and pain.
- The first 10-minute part of the CD audio recordings prepared by the Turkish Psychologists Association is about deep relaxation. purpose; The second 30-minute part includes instructions for relaxation exercises; The last 30 minutes are just it consists of relaxation music.
- In addition to standard treatment and care for laparoscopic cholecystectomy, volunteers who accept the study Progressive relaxation exercises were applied by the researcher at the 2nd, 6th, 12th and 24th hours after surgery.
When the literature review on PGE was made, it was seen that the application time and frequency of these exercises were not standard; 6th, 12th, 24th hours after surgery; It was applied on the 2nd day after surgery and the total number of sessions varied.
It is seen to show . In our study, PGE was detected at the 2nd, 6th, 12th and 24th hours after surgery.
has been implemented.Control group patients were informed about the research and received Informed Voluntary Consent Form (ANNEX-I) verbal and written permissions were obtained. - Before the surgery, the Patient Introduction Form (Annex-II) was checked both from the file and received verbal confirmation from the patient.
was filled in.
- The researcher was informed about the surgical intervention, expected nausea and vomiting, and pain.
- Patients in the control group were given the standard procedure for laparoscopic cholecystectomy only during the research period. treatment and care were applied.
- No postoperative intervention was performed on the control group, and the researcher did not perform surgery after surgery.
Visual Comparison Scale (ANNEX-III) form for the severity of pain, nausea and vomiting at the 2nd, 6th, 12th and 24th hours The patient is asked to mark it with a pen or verbally indicate the severity between 1 and 10 on the form.
marking has been made.
- After the postoperative pain, nausea and vomiting status is determined on the Visual Comparison Scale, perioperative Patient Follow-up Form (ANNEX-IV) has been filled out.
- Data collection process of the research in order to eliminate ethical problems that may occur in the control group After completion, these patients were trained in progressive relaxation exercises.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients in the study group underwent progressive relaxation exercises at the 2nd, 6th, 12th and 24th hours after surgery
| Arm | Type | Receives |
|---|---|---|
| Group 1 | No intervention | –Patients in the control group were given only the standard procedure for laparoscopic cholecystectomy during the research period. treatment and care were applied. |
| Group 2 | Experimental | Other: relaxation exercisesThe first 10-minute part of the CD audio recordings prepared by the Turkish Psychologists Association is about deep relaxation. purpose; The second 30-minute part includes instructions for relaxation exercises; The last 30 minutes are just It consists of relaxation music[145]. In our study, the instructions in the second part were used. - In addition to standard treatment and care for laparoscopic cholecystectomy, volunteers who accept the study Progressive relaxation exercises were applied by the researcher at the 2nd, 6th, 12th and 24th hours after surgery. When the literature review on PGE was made, it was seen that the application time and frequency of these exercises were not standard; 6th, 12th, 24th hours after surgery; It was applied on the 2nd day after surgery and the total number of sessions varied. It is seen to show. In our study, PGE was detected at the 2nd, 6t |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- *To participate in the research willing
Key exclusion criteria (13 listed)
- Under 18 and over 70 patients over (n=2)
- Agree to participate in the research not (n=12)
- Patients undergoing emergency surgery
- Prevents exercise with disease causing
- Hearing problem found
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 |
|---|---|---|
| relaxation exercisesThe first 10-minute part of the CD audio recordings prepared by the Turkish Psychologists Association is about deep relaxation. purpose; The second 30-minute part includes instructions for relaxation exercises; The last 30 minutes are just consists of relaxation music | Other | Group 2 |
Primary outcome
pain, nausea and vomiting 1
Time frame: at the 2nd hour after surgery
The severity of pain, nausea, and vomiting was assessed by the researcher at the 2nd hour using a visual analog scale.
3 secondary outcomes
pain, nausea and vomiting 2
Time frame: at the 6nd hours after surgery
pain, nausea and vomiting 3
Time frame: at the 12th hour after surgery
pain, nausea and vomiting 4
Time frame: at the 24th hour after surgery
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 19 Jul 2024.
- Individual participant dataSharing planned: No. no ipd
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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.
Didem LAFÇI, associate professor study director
Mersin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing relaxation exercises in people with Laparoscopic Cholecystectomy, run by Osmaniye Korkut Ata University at 1 site 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 8 inclusion and 13 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 19 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 1 site 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?
pain, nausea and vomiting 1 (time frame: at the 2nd hour after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jul 2024; AzTrials last refreshed its copy on 29 Oct 2026.