Patients of Laparoscopic CholecystectomyNCT06042114
The Effect of Listening to Surah Al-Inshirah on Pain and Anxiety After Laparoscopic Cholecystectomy Surgery
A study testing Surah Inshirah in people with Patients of Laparoscopic Cholecystectomy, run by Seher Tanrıverdi at 1 site in Turkey (Türkiye).
Trial summary
In the postoperative period, good pain and anxiety management is required to minimize complications and ensure recovery. Patients should be evaluated with a holistic approach, taking into account factors such as physical and psychological discomfort, anxiety level, age, gender, previous pain level. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients of Laparoscopic Cholecystectomy
- What is being tested?
- Surah Inshirah
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Sep 2023to 30 Nov 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who can be contacted,
- Patients with an abdominal pain score of 4 and above as evaluated by VAS after laparoscopic cholecystectomy surgery,
- Patients aged 18 and over were included in the study.
Who cannot join
- Patients who can be contacted,
- Patients with an abdominal pain score of 4 and above as evaluated by VAS after laparoscopic cholecystectomy surgery,
- Patients aged 18 and over were included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
In the postoperative period, good pain and anxiety management is required to minimize complications and ensure recovery. Patients should be evaluated with a holistic approach, taking into account factors such as physical and psychological discomfort, anxiety level, age, gender, previous pain level. Pharmacological and non-pharmacological methods are used to relieve pain and anxiety in the postoperative period.
Non-pharmacological methods reduce the patient's pain and anxiety by creating a feeling of comfort and control in the patient. Relaxation techniques such as hypnosis, yoga and music are among these. The main purpose of these methods is to draw the attention of the individual in another direction. Praying is also one of the non-drug methods, and the number of studies on this subject is very limited, and there are studies where it has been determined that praying and praying reduces the anxiety levels of patients.
Read more
Purpose To examine the effect of listening to Surah al-Inshirah on pain and anxiety after laparoscopic cholecystectomy surgery.
Method The population of the study will consist of patients who have undergone laparoscopic cholecystectomy at Mardin Training and Research Hospital and Kızıltepe State Hospital, who meet the inclusion criteria and volunteer to participate in the research.
The study group of 60 people who will participate in the research will be divided into two equal groups according to the table of random numbers obtained from the computer-based Research Randomizer program.
Experimental group patients; A patient descriptive characteristics form will be applied, pretest VAS pain score and state anxiety scale will be applied. Then, the Surah al-Inshirah will be listened to and the final test VAS pain score and state anxiety scale will be applied.
Control group patients; A patient descriptive characteristics form will be applied, pretest VAS pain score and state anxiety scale will be applied. The posttest VAS pain score and state anxiety scale will be applied 10 minutes later, without any intervention.
- Conditions
- Patients of Laparoscopic Cholecystectomy
- Being tested
- Surah Inshirah
- Keywords
- Laparoscopic Cholecystectomy, postoperative, pain, Surah Inshirah, anxiety
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surah InshirahBehavioural
Patients in the experimental group will be listened to the Surah al-Inshirah after surgery and its effect on pain and anxiety levels will be evaluated.
| Study group | Role | What they receive |
|---|---|---|
| Listening to Surah Inshirah | Experimental | Experimental group patients; A patient descriptive characteristics form will be applied, pretest VAS pain score and state anxiety scale will be applied. Then, the Surah al-Inshirah will be listened to and the final test VAS pain score and state anxiety scale will be applied. Receives: Behavioral: Surah Inshirah |
| control group | No intervention | Control group patients; A patient descriptive characteristics form will be applied, pretest VAS pain score and state anxiety scale will be applied. The posttest VAS pain score and state anxiety scale will be applied 10 minutes later, without any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Information Form
This form, created by the researcher with the support of the relevant literature, consists of 9 questions that question the patients' education level, age, gender, occupation, marital status, income level, previous surgery experience and coping methods used for pain and anxiety in daily life.
Measured: It will be applied to patients in the clinic 2 hours before the laparoscopic cholecystectomy procedure
Secondary outcomes (1)
Visual Analogue Scale (VAS)
The patient was asked to mark on a 10 cm horizontal line showing his current status on the Visual analog scale. In this study, for pain and anxiety; Markings were made on a 10 cm horizontal line, one end indicating that the patient's pain was very good (0 = no pain), and the other end indicating that the patient's pain was very bad (10 = most severe). The distance from the point where there was no pain or anxiety (0) to the point marked by the patient was measured. The value found shows the patient's pain and anxiety.
Measured: Change from initial Visual Analog Scale in 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start19 Sep 2023
- Primary completion19 Oct 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Patients of 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seher Tanrıverdi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Seher Tanrıverdi, Mardin Artuklu University
- Investigators
- SEHET TANRIVERDİ, PhD, Principal investigator, Mardin Artuklu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06042114
- Sponsor's protocol ID
- Mardin-Artuklu University
- Status last verified
- Jan 2024
- First submitted
- 8 Sep 2023
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: can be reviewed by other researchers after the study has been published.
Publications
Naimi E, Eilami O, Babuei A, Rezaei K, Moslemirad M. The Effect of Religious Intervention Using Prayer for Quality of Life and Psychological Status of Patients with Permanent Pacemaker. J Relig Health. 2020 Apr;59(2):920-927. doi: 10.1007/s10943-018-0698-8.
PubMed 30218372Acar, K., Aygin, D. (2016). Laparoskopik cerrahi sonrası ağrı ve hemşirelik bakımı. Online Türk Sağlık Bilimleri Dergisi, 1(2), 17-22.
Çakır, H.S.K., Yılmaz, Ü.D. (2018). Laparoskopik kolesistektomi uygulanan hastaların taburculuk öncesi bilgi gereksinimlerinin belirlenmesi. Türkiye Klinikleri Dergisi, 10(2), 115-121.
Cimilli, C. (2001). Cerrahide anksiyete. Klinik Psikiyatri, 4(3), 182-186. Erişim 27.08.2019, https://www.journalagent.com/kpd/pdfs/KPD_4_3_182_186.pdf
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Listening to Surah Al-Inshirah on Pain and Anxiety After Laparoscopic Cholecystectomy Surgery
- ClinicalTrials.gov ID
- NCT06042114
- Acronym / sponsor ID
- Mardin-Artuklu University
- Conditions
- Patients of Laparoscopic Cholecystectomy
- Keywords
- Laparoscopic Cholecystectomy, postoperative, pain, Surah Inshirah, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Seher TanrıverdiUniversity, hospital or other
- Study start
- 19 Sep 2023 (actual)
- Primary completion
- 19 Oct 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 18 Sep 2023 (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.
In the postoperative period, good pain and anxiety management is required to minimize complications and ensure recovery. Patients should be evaluated with a holistic approach, taking into account factors such as physical and psychological discomfort, anxiety level, age, gender, previous pain level. Pharmacological and non-pharmacological methods are used to relieve pain and anxiety in the postoperative period.
Non-pharmacological methods reduce the patient's pain and anxiety by creating a feeling of comfort and control in the patient. Relaxation techniques such as hypnosis, yoga and music are among these. The main purpose of these methods is to draw the attention of the individual in another direction. Praying is also one of the non-drug methods, and the number of studies on this subject is very limited, and there are studies where it has been determined that praying and praying reduces the anxiety levels of patients.
Purpose To examine the effect of listening to Surah al-Inshirah on pain and anxiety after laparoscopic cholecystectomy surgery.
Method The population of the study will consist of patients who have undergone laparoscopic cholecystectomy at Mardin Training and Research Hospital and Kızıltepe State Hospital, who meet the inclusion criteria and volunteer to participate in the research.
The study group of 60 people who will participate in the research will be divided into two equal groups according to the table of random numbers obtained from the computer-based Research Randomizer program.
Experimental group patients; A patient descriptive characteristics form will be applied, pretest VAS pain score and state anxiety scale will be applied. Then, the Surah al-Inshirah will be listened to and the final test VAS pain score and state anxiety scale will be applied.
Control group patients; A patient descriptive characteristics form will be applied, pretest VAS pain score and state anxiety scale will be applied. The posttest VAS pain score and state anxiety scale will be applied 10 minutes later, without any intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Listening to Surah Inshirah | Experimental | Behavioral: Surah InshirahExperimental group patients; A patient descriptive characteristics form will be applied, pretest VAS pain score and state anxiety scale will be applied. Then, the Surah al-Inshirah will be listened to and the final test VAS pain score and state anxiety scale will be applied. |
| control group | No intervention | –Control group patients; A patient descriptive characteristics form will be applied, pretest VAS pain score and state anxiety scale will be applied. The posttest VAS pain score and state anxiety scale will be applied 10 minutes later, without any intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who can be contacted,
Key exclusion criteria (3 listed)
- Patients who can be contacted,
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 |
|---|---|---|
| Surah InshirahPatients in the experimental group will be listened to the Surah al-Inshirah after surgery and its effect on pain and anxiety levels will be evaluated. | Behavioural | Listening to Surah Inshirah |
Primary outcome
Patient Information Form
Time frame: It will be applied to patients in the clinic 2 hours before the laparoscopic cholecystectomy procedure
This form, created by the researcher with the support of the relevant literature, consists of 9 questions that question the patients' education level, age, gender, occupation, marital status, income level, previous surgery experience and coping methods used for pain and anxiety in daily life.
1 secondary outcome
Visual Analogue Scale (VAS)
Time frame: Change from initial Visual Analog Scale in 10 minutes
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 1 Feb 2024.
- Background: PubMed 30218372Naimi E, Eilami O, Babuei A, Rezaei K, Moslemirad M. The Effect of Religious Intervention Using Prayer for Quality of Life and Psychological Status of Patients with Permanent Pacemaker. J Relig Health. 2020 Apr;59(2):920-927. doi: 10.1007/s10943-018-0698-8.
- Results publicationAcar, K., Aygin, D. (2016). Laparoskopik cerrahi sonrası ağrı ve hemşirelik bakımı. Online Türk Sağlık Bilimleri Dergisi, 1(2), 17-22.
- Results publicationÇakır, H.S.K., Yılmaz, Ü.D. (2018). Laparoskopik kolesistektomi uygulanan hastaların taburculuk öncesi bilgi gereksinimlerinin belirlenmesi. Türkiye Klinikleri Dergisi, 10(2), 115-121.
- Results publicationCimilli, C. (2001). Cerrahide anksiyete. Klinik Psikiyatri, 4(3), 182-186. Erişim 27.08.2019, https://www.journalagent.com/kpd/pdfs/KPD_4_3_182_186.pdf
- Individual participant dataSharing planned: No. can be reviewed by other researchers after the study has been published.
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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.
SEHET TANRIVERDİ, PhD principal investigator
Mardin Artuklu 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 Surah Inshirah in people with Patients of Laparoscopic Cholecystectomy, run by Seher Tanrıverdi 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 3 inclusion and 3 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 1 Feb 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?
Patient Information Form (time frame: It will be applied to patients in the clinic 2 hours before the laparoscopic cholecystectomy procedure). 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 NCT06042114, which also lists 4 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 1 Feb 2024.