xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06042114</url>
    </required_header>
    <id_info>
      <org_study_id>Mardin-Artuklu University</org_study_id>
      <nct_id>NCT06042114</nct_id>
    </id_info>
    <brief_title>The Effect of Listening to Surah Al-Inshirah on Pain and Anxiety After Laparoscopic Cholecystectomy Surgery</brief_title>
    <official_title>The Effect of Listening to Surah Al-Inshirah on Pain and Anxiety After Laparoscopic Cholecystectomy Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Seher Tanrıverdi</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Mardin Artuklu University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        In the postoperative period, good pain and anxiety management is required to minimize&#xD;
        complications and ensure recovery. Patients should be evaluated with a holistic approach,&#xD;
        taking into account factors such as physical and psychological discomfort, anxiety level,&#xD;
        age, gender, previous pain level. Pharmacological and non-pharmacological methods are used to&#xD;
        relieve pain and anxiety in the postoperative period.&#xD;
  &#xD;
        Non-pharmacological methods reduce the patient's pain and anxiety by creating a feeling of&#xD;
        comfort and control in the patient. Relaxation techniques such as hypnosis, yoga and music&#xD;
        are among these. The main purpose of these methods is to draw the attention of the individual&#xD;
        in another direction. Praying is also one of the non-drug methods, and the number of studies&#xD;
        on this subject is very limited, and there are studies where it has been determined that&#xD;
        praying and praying reduces the anxiety levels of patients.&#xD;
  &#xD;
        Purpose To examine the effect of listening to Surah al-Inshirah on pain and anxiety after&#xD;
        laparoscopic cholecystectomy surgery.&#xD;
  &#xD;
        Method The population of the study will consist of patients who have undergone laparoscopic&#xD;
        cholecystectomy at Mardin Training and Research Hospital and Kızıltepe State Hospital, who&#xD;
        meet the inclusion criteria and volunteer to participate in the research.&#xD;
  &#xD;
        The study group of 60 people who will participate in the research will be divided into two&#xD;
        equal groups according to the table of random numbers obtained from the computer-based&#xD;
        Research Randomizer program.&#xD;
  &#xD;
        Experimental group patients; A patient descriptive characteristics form will be applied,&#xD;
        pretest VAS pain score and state anxiety scale will be applied. Then, the Surah al-Inshirah&#xD;
        will be listened to and the final test VAS pain score and state anxiety scale will be&#xD;
        applied.&#xD;
  &#xD;
        Control group patients; A patient descriptive characteristics form will be applied, pretest&#xD;
        VAS pain score and state anxiety scale will be applied. The posttest VAS pain score and state&#xD;
        anxiety scale will be applied 10 minutes later, without any intervention.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">November 2023</completion_date>
    <primary_completion_date type="Anticipated">October 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Patient Information Form</measure>
      <time_frame>It will be applied to patients in the clinic 2 hours before the laparoscopic cholecystectomy procedure</time_frame>
      <description>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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Visual Analogue Scale (VAS)</measure>
      <time_frame>Change from initial Visual Analog Scale in 10 minutes</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Patients of Laparoscopic Cholecystectomy</condition>
    <arm_group>
      <arm_group_label>Listening to Surah Inshirah</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Surah Inshirah</intervention_name>
      <description>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.</description>
      <arm_group_label>Listening to Surah Inshirah</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients who can be contacted,&#xD;
  &#xD;
                 -  Patients with an abdominal pain score of 4 and above as evaluated by VAS after&#xD;
                    laparoscopic cholecystectomy surgery,&#xD;
  &#xD;
                 -  Patients aged 18 and over were included in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who can be contacted,&#xD;
  &#xD;
                 -  Patients with an abdominal pain score of 4 and above as evaluated by VAS after&#xD;
                    laparoscopic cholecystectomy surgery,&#xD;
  &#xD;
                 -  Patients aged 18 and over were included in the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>SEHET TANRIVERDİ, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Mardin Artuklu University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>SEHER TANRIVERDİ, PhD</last_name>
      <phone>05469038921</phone>
      <email>sehertanriverdi@artuklu.edu.tr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Mardin State Hospital</name>
        <address>
          <city>Mardi̇n</city>
          <country>Turkey</country>
        </address>
      </facility>
      <contact>
        <last_name>SEHER TANRIVERDİ, PhD</last_name>
        <phone>05469038921</phone>
        <email>sehertanriverdi@artuklu.edu.tr</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>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.</citation>
      <PMID>30218372</PMID>
    </reference>
    <results_reference>
      <citation>Acar, K., Aygin, D. (2016). Laparoskopik cerrahi sonrası ağrı ve hemşirelik bakımı. Online Türk Sağlık Bilimleri Dergisi, 1(2), 17-22.</citation>
    </results_reference>
    <results_reference>
      <citation>Çakır, H.S.K., Yılmaz, Ü.D. (2018). Laparoskopik kolesistektomi uygulanan hastaların taburculuk öncesi bilgi gereksinimlerinin belirlenmesi. Türkiye Klinikleri Dergisi, 10(2), 115-121.</citation>
    </results_reference>
    <results_reference>
      <citation>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</citation>
    </results_reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 15, 2023</last_update_submitted>
    <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Mardin Artuklu University</investigator_affiliation>
      <investigator_full_name>Seher Tanrıverdi</investigator_full_name>
      <investigator_title>Asistant Professor</investigator_title>
    </responsible_party>
    <keyword>Laparoscopic Cholecystectomy</keyword>
    <keyword>postoperative</keyword>
    <keyword>pain</keyword>
    <keyword>Surah Inshirah</keyword>
    <keyword>anxiety</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>can be reviewed by other researchers after the study has been published.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06042114
  org study id: Mardin-Artuklu University
  nct id: NCT06042114
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Patient Information Form
  time frame: It will be applied to patients in the clinic 2 hours before the laparoscopic cholecystectomy procedure
  description: 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.
  measure: Visual Analogue Scale (VAS)
  time frame: Change from initial Visual Analog Scale in 10 minutes
  description: 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.
  arm group label: Listening to Surah Inshirah
  arm group type: Experimental
  description: 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.
  arm group label: control group
  arm group type: No Intervention
  description: 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.
  intervention type: Behavioral
  intervention name: Surah Inshirah
  description: 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.
  arm group label: Listening to Surah Inshirah
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: SEHET TANRIVERDİ, PhD
  role: Principal Investigator
  affiliation: Mardin Artuklu University
  last name: SEHER TANRIVERDİ, PhD
  phone: 05469038921
  email: sehertanriverdi@artuklu.edu.tr
  facility: 
  contact: 
  country: Turkey
  citation: 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: 30218372
  citation: Acar, K., Aygin, D. (2016). Laparoskopik cerrahi sonrası ağrı ve hemşirelik bakımı. Online Türk Sağlık Bilimleri Dergisi, 1(2), 17-22.
  citation: Çakır, H.S.K., Yılmaz, Ü.D. (2018). Laparoskopik kolesistektomi uygulanan hastaların taburculuk öncesi bilgi gereksinimlerinin belirlenmesi. Türkiye Klinikleri Dergisi, 10(2), 115-121.
  citation: 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
  responsible party type: Sponsor-Investigator
  investigator affiliation: Mardin Artuklu University
  investigator full name: Seher Tanrıverdi
  investigator title: Asistant Professor
  sharing ipd: No
  ipd description: can be reviewed by other researchers after the study has been published.