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Investigation the effect of spiritual care education on postpartum stress disorder in women with preeclampsia

Protocol summary

Summary
This study was conducted to determine” the effect of spiritual care education on postpartum stress disorder in women with preeclampsia”. In this randomized clinical trial, 72 women (36 in each group) were selected in a convenience way from pregnant women between the ages of 32-38 weeks and older who had severe and non-severe preeclampsia and admitted to two public hospitals in Mashhad (Imam Reza and Qa'im Hospital). The research units completed the questionnaires Spiritual Well Ellison & Paloutzian, Being Scale (SWBS) , DASS21 and Duke University Religion Index in the beginning. Then they were evaluated for the symptoms by The post traumatic Disorder checklist (PCL).They will be excluded from the study, if they answer yes to any questions. Multigravida suffering from post-traumatic stress disorder fulfilled also Prenatal Posttraumatic Stress Questionnaire (PPQ).Women will be excluded from the study if they earn a score of over 6. Research units were randomly assigned to two groups of intervention and control. To do this, two bags with two envelopes in each were selected. In the first bag, the names of the Imam Reza and Qa'im Hospital were written on the envelopes. In the second bag, the intervention and control group. Then, randomly, we took a packet of the first bag and an envelope of the second bag. This will determine which hospital is the intervention group and which hospital will be the control group. In the intervention group, firstly, women were educated based on Richards and Bergin pattern, focusing on the religion of Islam, after confirmation by religious experts. Three face to face sessions, which lasted 35 to 60 min were held each day. The intervention pack was also provided on a CD for the mothers to do at home. The researcher maintained and strengthened his contact with research units through phone calls and checklists. Mothers visited the midwifery department of these hospitals and covered health centers once every two weeks to present their spiritual care checklist. And in the middle of the week, they received phone call. The control group also received routine cares. All units were asked to visit the clinics at the 4th to 6th postpartum period in order to control the blood pressure. Both groups completed questionnaires Spiritual Well Ellison & Paloutzian, DASS21 and The post traumatic Disorder checklist (PCL). Results were analyzed in two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017042728911N2
Registration date: 2017-08-26, 1396/06/04
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-08-26, 1396/06/04
Registrant information
Name
Zahra Kamali
Name of organization / entity
Department of Midwifery, School of Nursing and Midwifery, Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1511
Email address
kamaliz921@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Mashhad University of Medical Sciences.
Expected recruitment start date
2017-05-02, 1396/02/12
Expected recruitment end date
2017-09-03, 1396/06/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effect of spiritual care education on postpartum stress disorder in women with preeclampsia
Public title
Investigation the effect of spiritual care education on postpartum stress disorder
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Having preeclampsia; Singleton pregnancy and live fetus; gestational age between 32 to 38 week; Iranian citizenship and settle in Mashhad; Having reading and writing ability; Participation in the study; Having a contact number. Exclusion criteria: Having medical conditions; Having obstetric complications apart from preeclampsia; The use of tobacco and drugs; Suicide or thinking about suicide during the past year; Having a history of mental illness or taking psychiatric drugs; Having History of infertility; Having a history of two abortions and more; Getting a score of over 6 from post-traumatic stress disorder (PPQ) questionnaire in women multipar; Getting more and more severe scores from the DASS 21 questionnaire in the subscales of anxiety, stress, depression; Getting score above 50 from the post traumatic Disorder checklist (PCL) questionnaire.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
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 Mashhad University of Medical Sciences
Street address
Next to the cinema Hoveizeh, University Avenue, Vice Chancellor for Research and Technology, Mashhad University of Medical Sciences, Mashhad.
City
Mashhad
Postal code
00985138411538
Approval date
2017-03-11, 1395/12/21
Ethics committee reference number
IR.MUMS.REC.1395.618

Health conditions studied

1

Description of health condition studied
Preeclampsia
ICD-10 code
O10, O11,
ICD-10 code description
Oedema, proteinuria and hypertensive disorders in pregnancy, childbirth and the puerperium

Primary outcomes

1

Description
Anxiety, Stress, Depression
Timepoint
Before intervention and Four weeks after childbirth
Method of measurement
Questionnaire DASS21

2

Description
Spiritual Health
Timepoint
Before intervention and Four weeks after childbirth.
Method of measurement
The questionnaires Spiritual Well Ellison & Paloutzian, Being Scale (SWBS)

Secondary outcomes

1

Description
The Post-traumatic stress disorder after childbirth
Timepoint
Four weeks after giving birth.
Method of measurement
Instruments Prenatal post traumatic stress question are ( PPQ),

Intervention groups

1

Description
The training Spiritual Care intervention was applied in 3 sessions, each 45-60 min in face-to-face. Session Contents: At the first session: A) Meeting people and assessing the knowledge, attitudes and beliefs of patients and listening to patients' views on spiritual issues, religion and existential issues (separately). B) The role of the reading Qur'an and praying and in felling calm C) Positive statements based on the Quran and Hadith books. At the second session: A) Repent and seek forgiveness B) Story of religious people C) Participate in religious programs D) Addressing God and accept the current situation E) Trust, resort, patience, charity (kindness and forgiveness) and focus on the blessings of God At the third session: A) explaining the experience of spiritual care and its effects B) Use the consequences of this care and summarize the past sessions During the sessions, the following spiritual care was also provided: 1) Trust, empathy and honesty between the nurse and mothers to establish a proper communication during the sessions. 2) Listen carefully to the physical & mental problems, worries and fears of patients 3) Psychological support required by patients 4) Strengthening individuals' inner hope and powers 5) Using positive energy sentences and strengthen healthy and constructive thoughts 6) Helping the patient find the meaning of life and understanding that none of the life events is beyond the destiny. who believes in God over whole world could be saves from the feeling pessimistic, emptiness and frustrated 7) Providing the necessary facilities for religious practices 8) Encouraging the patient to read Qur'an and pray 9) touching the hands of patients in order to provide them with mental support 10) Encouraging the patient to express their religious beliefs 11) Encouraging patients to visit religious clerics 12) Encouraging patients to refer to people who feel comfortable with them 13) Encouraging patients to enjoy entertainment and do light sports activities according to their physician's opinion. 14) Assuring the patient that the nurse is always available to her clients for mental and psychological support. 15) seek forgiveness from past sins and forsaking anger against the perpetrator and guilty person 16) Encouraging the mothers to enjoy music, singing, theater, cinema, art and etc. 17) Encourage the patients to establish a friendly relationship with others 18) Encouraging the patients to laugh and do their favorite hobbies 19) Encouraging the patients to participate in religious services and social gatherings
Category
N/A

2

Description
The control group received routine care.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Zahra Kamali
Street address
Crossroads PhD, Ibn Sina Street, Square Imam Reza
City
Mashhad

2

Recruitment center
Name of recruitment center
Ghaem Hospital.
Full name of responsible person
Zahra Kamali
Street address
Ahmadabad, square Doctor Shariati.
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences, Vice Chancellor for Research and Technology
Full name of responsible person
Dr Mohsen Tafaqodi (Deputy of Research and Technology)
Street address
Next to the cinema Hoveizeh, University Avenue, Vice Chancellor for Research and Technology, Mashhad University of Medical Sciences, Mashhad.
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences, Vice Chancellor for Research and Technology
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
School of Nursing and Midwifery, Mashhad University of Medical Sciences, Mashhad, Iran.
Full name of responsible person
Zahra Kamali
Position
Masters Student
Other areas of specialty/work
Street address
University Avenue, Crossroads PhD, Ibn Sina Street, School of Nursing and Midwifery, Mashhad.
City
Mashhad
Postal code
00985138591511
Phone
+98 51 3859 1511
Fax
Email
kamaliz921@mums.ac.ir؛ kamalishahla6@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Lecturer, Department of Midwifery, School of Nursing and Midwifery, Mashhad University of Medical Sc
Full name of responsible person
Mahin Tafazoli
Position
Midwifery Training
Other areas of specialty/work
Street address
University Avenue, Crossroads PhD, Ibn Sina Street, School of Nursing and Midwifery, Mashhad
City
Mashhad
Postal code
Phone
+98 51 3859 1511
Fax
Email
Tafazolim@mums.ac.ir ؛ http://www.mums.ac.ir/nurse
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Omid Kiani
Position
Biostatistics Student
Other areas of specialty/work
Street address
University 18, University Avenue, Mashhad School of Public Health, Mashhad
City
Mashhad
Postal code
00985138515116
Phone
+51 38591514
Fax
Email
kamalishahla6@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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