- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06042114
The Effect of Listening to Surah Al-Inshirah on Pain and Anxiety After Laparoscopic Cholecystectomy Surgery
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Mardi̇n, Turkey
- Mardin State Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Listening to Surah Inshirah
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.
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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.
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No Intervention: control group
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Information Form
Time Frame: It will be applied to patients in the clinic 2 hours before the laparoscopic cholecystectomy procedure
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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.
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It will be applied to patients in the clinic 2 hours before the laparoscopic cholecystectomy procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analogue Scale (VAS)
Time Frame: Change from initial Visual Analog Scale in 10 minutes
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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.
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Change from initial Visual Analog Scale in 10 minutes
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: SEHET TANRIVERDİ, PhD, Mardin Artuklu University
Publications and helpful links
General 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.
- Acar, 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 record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Mardin-Artuklu University
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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