1. Home
  2. Approved trials
  3. » فارسی

Effect of dhikr (God’s remembrance) and routine care on perioperative anxiety of cesarean section among Shia Muslims

Protocol summary

Study aim
Evaluating the effect of reciting "Tasbihat Hazrat Fatimah al-Zahra (PBUH)" on the anxiety of cesarean surgery
Design
This clinical trial will be conducted on 50 samples. Randomization will be centralized and computerized with concealed randomization sequences.
Settings and conduct
The study will be conducted on 50 candidates for elective cesarean surgery at two teaching hospitals in Khuzestan province (i.e., Taleghani in Abadan and Valiasr in Khorramshahr). The eligible participants will be sequentially allocated to two equal groups of control and experimental, using a random number generator software. The participants and the nurses, who will supervise and coordinate the study intervention, are not blinded due to the character of the intervention. Nevertheless, all scorings in the two groups will undertake under the surveillance of a blinded nurse.
Participants/Inclusion and exclusion criteria
Inclusion criteria: aged 18-35 years, having a gestational age of 38-42 weeks, following Shia religion, having a moderate-to-high religious belief, believing in dhikr practice and having a low-to-moderate tendency toward it, experiencing mild preoperative anxiety. Exclusion criteria: an addiction to opioids or alcohol, being candidates for other surgeries accompanied by cesarean section, utilizing anti-anxiety non-pharmacological interventions or taking anxiolytics, analgesics, tranquilizers, or sedatives before admission.
Intervention groups
The participants in the control and experimental groups will receive routine surgical care. However, those in the experimental group will also receive a 4-session dhikr-based program.
Main outcome variables
Anxiety before and after cesarean surgery

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130803014251N9
Registration date: 2023-06-02, 1402/03/12
Registration timing: registered_while_recruiting

Last update: 2023-06-02, 1402/03/12
Update count: 0
Registration date
2023-06-02, 1402/03/12
Registrant information
Name
MORTEZA NASIRI
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 77 2622 5292
Email address
nasiri.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-17, 1402/02/27
Expected recruitment end date
2023-07-23, 1402/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of dhikr (God’s remembrance) and routine care on perioperative anxiety of cesarean section among Shia Muslims
Public title
Effect of dhikr on cesarean section-induced anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18-35 years Having a gestational age of 38-42 weeks, and an uncomplicated singleton pregnancy Following Shia religion Having a moderate-to-high religious belief based on Muslim Religiosity Questionnaire score of >26 Believing in dhikr practice and having a low-to-moderate tendency toward it with obtaining a score of <69 in the Tendency to Dhikr Questionnaire Experiencing mild preoperative anxiety with Visual Analog Scale for Anxiety (VAS-A) score <44 millimeters (mm) A minimum level of literacy and capability to communicate and speak in Persian Belonging to American Society of Anesthesiologists (ASA) class I or II
Exclusion criteria:
Addiction to opioids or alcoholic beverages Having other surgeries accompanied by cesarean surgery (e.g., myomectomy, tubal ligation, and hysterectomy) Utilizing anti-anxiety non-pharmacological interventions or taking anxiolytics, analgesics, tranquilizers, or sedatives before admission Suffering from psychiatric illnesses or chronic diseases (e.g., asthma, diabetes, and severe heart diseases)
Age
From 18 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
The eligible participants will be selected using a convenience sampling method. Then, after stratifying by parity and cesarean surgery indication, they will be sequentially allocated to two groups of control and experimental, using a random number generator software. To this end, each newly admitted participant will be allocated a random number from 1-50. Consequently, participants will be assigned to control and experimental groups if the allocated number is 1-25 and 26-50, respectively. Allocation concealment will be assured by using clinician-controlled randomization. To this purpose, sampling and randomization will be accomplished by a researcher assistant, who will be unaware of the aim of this trial and will be the only individual with access to group allocations.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Abadan University of Medical Sciences
Street address
Building of Abadan University of Medical Sciences, Zulfaqari, 30M street, Abadan, Khuzestan province, Iran
City
Abadan
Province
Khouzestan
Postal code
6319811154
Approval date
2023-03-13, 1401/12/22
Ethics committee reference number
IR.ABADANUMS.REC.1401.166

Health conditions studied

1

Description of health condition studied
Anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition

Primary outcomes

1

Description
Cesarean section-induced anxiety
Timepoint
Seven-time points as follows: T1) the day before surgery in the preoperative ward: before random allocation as the baseline, T2) the day of surgery in the preoperative unit: immediately before transferring participants from the preoperative ward to the operating room, T3) the day of surgery in the surgical waiting room: 5 minutes after admitting participants to the operating room, T4) the day of surgery in the surgical waiting room: immediately before transferring participants from the surgical waiting area to the surgery room, T5) the day of surgery in the surgery room: immediately before the initiation of surgery, T6) the day of surgery in the postoperative ward: instantly after admitting participants to the postoperative department, and T7) the day of surgery in the postoperative unit: 7 hours after the participants’ admission to the post-surgery department.
Method of measurement
Visual Analog Scale for Anxiety (VAS-A)

Secondary outcomes

1

Description
Adverse events of intervention
Timepoint
During intervention
Method of measurement
Checklist: nurses’ observations and participants’ self-reports

Intervention groups

1

Description
Intervention group: The participants in the experimental group will receive surgical preparation and perioperative care based on the standard protocols of the recruitment hospitals. Additionally, they will receive a dhikr-based program in four sessions as follow: 1) the night before surgery (i.e., 8:00-10:00 PM) in the preoperative ward, 2) the surgery day: ten minutes after the participant’s admission to the OR, conducted on the surgical waiting room, 3) the surgery day: immediately after admitting participant to the surgery room, and 4) the surgery day: six hours after admitting participant to the postoperative unit. At each session, participants slowly and verbally recite phrases of “Tasbihat Hazrat Fatimah al-Zahra (SA)” for 15 minutes.
Category
Treatment - Other

2

Description
Control group: The participants in the control group will receive surgical preparation and perioperative care the same as the experimental group based on the standard protocols of the recruitment hospitals.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Masoomeh Asadi
Street address
In front of Islamic Azad University, Abadan, Khuzestan province, Iran
City
Abadan
Province
Khouzestan
Postal code
6319811154
Phone
+98 939 751 7636
Fax
+98 61 5336 1030
Email
M.asadi@abadanums.ac.ir
Web page address
https://taleghani.abadanums.ac.ir/portal/home/?317016/%D8%AA%D9%85%D8%A7%D8%B3-%D8%A8%D8%A7-%D9%85%D8%A7

2

Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Masoomeh Asadi
Street address
Ayatollah Taleghani avenue, Khorramshahr, Khuzestan province, Iran
City
Khorramshahr
Province
Khouzestan
Postal code
6418733891
Phone
+98 61 5354 4800
Email
M.asadi@abadanums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Abadan University of Medical Sciences
Full name of responsible person
Dr. Seyed Mohammad Mohammadi
Street address
Building of Abadan University of Medical Sciences, Zulfaqari, 30M street, Abadan, Khuzestan province, Iran
City
Abadan
Province
Khouzestan
Postal code
6319811154
Phone
+98 61 5338 4004
Email
Mohammadi-sm@ajums.ac.ir
Web page address
https://abadanums.ac.ir/Portal/Home/
Grant name
Grant code / Reference number
1548
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Abadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Abadan University of Medical Sciences
Full name of responsible person
Masoomeh Asadi
Position
Instructor, Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Building of Abadan University of Medical Sciences, Zulfaqari, 30M street, Abadan, Khuzestan province, Iran
City
Abadan
Province
Khouzestan
Postal code
6319811154
Phone
+98 61 5338 4004
Email
M.asadi@abadanums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Morteza Nasiri
Position
Assistant professor of operating room
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
No.17, Fardanesh Alley, Qods Street, Enqelab Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
44361-14177
Phone
+98 21 8898 2905
Email
Mortezanasiri.or87@yahoo.com
Web page address
https://paramed.tums.ac.ir/fa

Person responsible for updating data

Contact
Name of organization / entity
Behbahan University of Medical Sciences
Full name of responsible person
Fakhridokht Akbari
Position
Instructor of nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Zibaee Street, Behbahan, Khuzestan province, Iran
City
Behbahan
Province
Khouzestan
Postal code
6361796819
Phone
+98 61 5283 9011
Email
Akbari@behums.ac.ir
Web page address
https://www.behums.ac.ir/

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Only a part of patients' demographical data and main outcomes will be shared.
When the data will become available and for how long
After the publishing of the results
To whom data/document is available
Data will be available only for researchers working on academic and university associations.
Under which criteria data/document could be used
Mention of study details and authors name
From where data/document is obtainable
Morteza Nasiri: Department of Operating Room, School of Allied Medical Sciences, Tehran University of Medical Sciences, Tehran, Iran
What processes are involved for a request to access data/document
Information will provide via the following email upon request. Mortezanasiri.or87@yahoo.com
Comments
Loading...