NCT06042114

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 18, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

September 19, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 19, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

February 1, 2024

Status Verified

January 1, 2024

Enrollment Period

1 month

First QC Date

September 8, 2023

Last Update Submit

January 30, 2024

Conditions

Keywords

Laparoscopic CholecystectomypostoperativepainSurah Inshirahanxiety

Outcome Measures

Primary Outcomes (1)

  • 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.

    It will be applied to patients in the clinic 2 hours before the laparoscopic cholecystectomy procedure

Secondary Outcomes (1)

  • Visual Analogue Scale (VAS)

    Change from initial Visual Analog Scale in 10 minutes

Study Arms (2)

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.

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.

Interventions

Surah InshirahBEHAVIORAL

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.

Listening to Surah Inshirah

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mardin State Hospital

Mardin, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 30218372BACKGROUND
  • Acar, K., Aygin, D. (2016). Laparoskopik cerrahi sonrası ağrı ve hemşirelik bakımı. Online Türk Sağlık Bilimleri Dergisi, 1(2), 17-22.

    RESULT
  • Çakır, H.S.K., Yılmaz, Ü.D. (2018). Laparoskopik kolesistektomi uygulanan hastaların taburculuk öncesi bilgi gereksinimlerinin belirlenmesi. Türkiye Klinikleri Dergisi, 10(2), 115-121.

    RESULT
  • 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

    RESULT

MeSH Terms

Conditions

PainAnxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • SEHET TANRIVERDİ, PhD

    Mardin Artuklu University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Asistant Professor

Study Record Dates

First Submitted

September 8, 2023

First Posted

September 18, 2023

Study Start

September 19, 2023

Primary Completion

October 19, 2023

Study Completion

November 30, 2023

Last Updated

February 1, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

can be reviewed by other researchers after the study has been published.

Locations