The effect of spiritual practice along routine medical care on the recovery of patients hospitalized with Covid-19: a randomized clinical trial
Design
A clinical trial with two intervention and comparison groups, a blind, randomized, block-assisted strain will be performed on 70 patients with Covid-19.
Settings and conduct
Imam Hussein Hospital
The patient will be asked to provide spiritual care for 7 days. The intervention lasts one week, three times a day for 10 minutes each time, a total of 21 sessions. According to previous clinical trials, Surah Hamd and Zikr "Ya Allah" (from the divine names) which has been used in previous studies for the recovery of patients were selected.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
positive PCR
hospitalized
Exclusion criteria:
Any clinical condition that affects a person's ability to participate in a spiritual self-care program
ICU admission
Teenagers and children
Pregnancy
Intervention groups
The intervention group will recite Surah Al-Hamd three times and 'Ya Allah' 66 times in spiritual practice(comparison group: without spiritual practice).
Main outcome variables
Vital signs
HADS Questionnaire
Duration of hospitalization
Transfer to ICU and death
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201101049219N1
Registration date:2021-06-10, 1400/03/20
Registration timing:retrospective
Last update:2021-06-10, 1400/03/20
Update count:0
Registration date
2021-06-10, 1400/03/20
Registrant information
Name
Batool Mousavi
Name of organization / entity
Janbazan Medical and Engineering Research Center (JMERC), Tehran, Iran
Country
Iran (Islamic Republic of)
Phone
+98 21 2241 6699
Email address
mousavi.b@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2020-12-05, 1399/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of spiritual practice along routine medical care on the recovery of patients hospitalized with Covid-19: a randomized clinical trial
Public title
Effects of spiritual practice on recovery of Covid-19
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with positive Covid-19 test report.
Patients hospitalized due to Covid-19.
Exclusion criteria:
Any clinical condition that affects a person's ability to participate in a spiritual self-care program, such as diagnosed psychological problems.
Any clinical condition that may limit the patient spiritual practice such as drowsiness or decrease level of consciousness.
ICU addmision
Teenagers and children
Pregnancy
Age
From 20 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, patients were first divided into two groups: less than 60 years and 60 years and more. Then, in order to assign the patient to the intervention or control group in this study, the method of randomization blocks with a volume of 4 was used. These blocks were prepared in R software using the blockrand package. If there is an admission order in the file of each patient, the patient who accepts the conditions for admission to the study, if the patient is 60 years and older, enters the study using randomly defined blocks of volume 4 for people 60 years and older And if he is less than 60 years old, he enters the study using other randomly defined blocks for people under 60 years old. The patient is assigned to the intervention or comparison group in the same way according to the random table, and the next individuals are included in the study in the same way according to the random table. There is no concealment in this study.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the patient and the researcher are in the intervention and comparison group, while the other members, including the clinical caregiver, outcome assessor, and data analyzer, do not know which patients are in which study group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research ethics committee veterans and martyrs affair foundation (VMAF)
U07.1:Confirmed cases of COVID-19 with positive or presumptive-positive test results
Primary outcomes
1
Description
According to the hospital stress and anxiety questionnaire, the score of hospital anxiety will be measured in patients with Covid-19 before and after the intervention. At the beginning of the study, a hospital anxiety questionnaire will be completed for all participants. Then the intervention will be done. After the intervention on the seventh day, the hospital anxiety questionnaire will be completed for the patients.
Timepoint
Hospital anxiety will be measured at the beginning of the study before the intervention and on the seventh day.
Method of measurement
Hospital Anxiety and Depression Scale
Secondary outcomes
empty
Intervention groups
1
Description
In this study, participants are divided into two groups of intervention and control. The intervention group, in addition to the usual treatments prescribed by doctors in the hospital, receives a spiritual-religious care package that includes a seven-day period and three times a day reciting dhikr or Allah and Surah Hamad. Thus, the patient who has entered the intervention group for seven days should recite Surah Al-Hamd 3 times and Zikr Ya Allah 66 times every morning, noon and night. In order to remind, a table has been prepared that the patient enters in the table every time he recites the dhikr. Saying dhikrs is controlled and reminded daily by the researcher who is present in the hospital. The intervention is non-invasive and does not interfere with other treatment processes.
Category
Rehabilitation
2
Description
Control group: Control group: Control group: Patients in the control group receive only the usual treatments prescribed by doctors in the hospital.