The effect of counseling with spirituality-oriented approach on quality of life after childbirth in women with preeclampsia
Design
Phase 3 is a randomized controlled clinical trial with parallel groups that will be performed on 40 patients (20 intervention patients, 20 control patients). We do not have blindness. Eligible women will be selected by the available method and will be assigned to the intervention and control groups by the 4-item random block method using a random number table.
Settings and conduct
The research environment includes the postpartum ward of Ayatollah Mousavi Hospital in Zanjan and the study population including postpartum women with preeclampsia admitted to the ward by simple sampling method and then randomly assigned to the control and intervention groups in a block of 4.
Participants/Inclusion and exclusion criteria
Preeclampsia- Hospitalization less than 5 days-No other chronic diseases (diabetes - kidney disease - cancer)
Not having a known mental illness- Willingness to participate in the study-Having a delivery with a singleton pregnancy, without known neonatal abnormalities - Intrauterine death of the baby
Literacy for reading and writing-Score less than 22 based on the -GHQ-28 General Health Questionnaire
Intervention groups
The individual counseling intervention group with a spirituality-based approach based on Richards and Bergin's pattern protocol, will be held in 5 sessions. Three face-to-face counseling sessions for 45-60 minutes during hospital stay and two sessions of postpartum telephone counseling weekly after discharge. . The control group will receive routine care.
Main outcome variables
Quality of life, preeclampsia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150731023423N16
Registration date:2020-10-01, 1399/07/10
Registration timing:registered_while_recruiting
Last update:2020-10-01, 1399/07/10
Update count:1
Registration date
2020-10-01, 1399/07/10
Registrant information
Name
Azam Maleki
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 3345 4264
Email address
malekia@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-20, 1399/06/30
Expected recruitment end date
2021-03-18, 1399/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of counseling with spirituality-oriented approach on quality of life after childbirth in women with preeclampsia
Public title
The effect of spirituality counseling on the quality of life of preeclamptic women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
- Preeclampsia - Hospitalization less than 5 days - No other concomitant chronic diseases (diabetes - Kidney disease - Cancer) - No known mental illness - Willingness to participate in the study - Having a delivery with a singleton pregnancy, withoabnormalities Known Infant - Intrauterine Infant Death -Literacy for reading and writing - Score less than 22 based on GHQ-28 General Health Questionnaire
- Hospitalization less than 5 days
- No other concomitant chronic diseases (diabetes - Kidney disease - Cancer)
- No known mental illness
- Willingness to participate in the study
- Having a delivery with a singleton pregnancy, withoabnormalities Known Infant - Intrauterine Infant Death
-Literacy for reading and writing
- Score less than 22 based on GHQ-28 General Health Questionnaire
Exclusion criteria:
Having postpartum complications (bleeding, infection, etc.)
Infant death
Reluctance to continue cooperation in the study
Changing the treatment process (eg transfer to the intensive care unit)
Failure to answer a phone call during the follow-up period
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible samples will be selected by convenience sampling method and then randomly assigned to 4 control and intervention groups of 4 blocks. For the intervention group, one-on-one counseling with a spirituality-based approach based on the Richards and Bergin's pattern protocol will be held in 5 sessions. Three face-to-face counseling sessions for 45-60 minutes during hospital stay and two sessions of postpartum telephone counseling weekly after discharge. (39, 43). The control group will receive routine care. Data collection tools include demographic characteristics questionnaire, postpartum quality of life questionnaire, general health questionnaire: GHQ and DSES questionnaire (daily spiritual experiences) which in two stages before the intervention and 6 weeks after the end of counseling sessions by research units. Complete and will be analyzed using SPSS statistical software version 20 and statistical methods of chi-square, independent t-test and paired t-test, MANCOVA statistical methods and multivariate analysis of variance MANOVA in case of abnormal distribution of non-parametric tests The equivalent will be used.
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 Zanjan University of Medical Sciences
Street address
Zanjan Azadi Blvd. Zanjan University of Medical Sciences
City
Zanjan
Province
Zanjan
Postal code
4515613191
Approval date
2019-12-10, 1398/09/19
Ethics committee reference number
IR.ZUMS.REC.1398.376
Health conditions studied
1
Description of health condition studied
Quality of life after childbirth in women with preeclampsia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The effect of spirituality-oriented counseling on quality of life after childbirth in women with preeclampsia
Timepoint
Three sessions of spiritual counseling modeled on Richards and Bergin, in person for 45-60 minutes during hospital stay and two sessions of telephone counseling weekly after discharge
Method of measurement
, Postpartum Quality of Life Questionnaire, General Health Questionnaire: GHQ, DSES Questionnaire (Daily Spiritual Experiences)
2
Description
Quality of life after childbirth in women with preeclampsia
Timepoint
Three sessions of spiritual counseling modeled on Richards and Bergin, in person for 45-60 minutes during hospital stay and two sessions of telephone counseling weekly after discharge
Method of measurement
Postpartum Quality of Life Questionnaire, General Health Questionnaire: GHQ, DSES Questionnaire (Daily Spiritual Experiences)
Secondary outcomes
1
Description
Quality of Life
Timepoint
In two stages before the intervention and 6 weeks after the end of the consultation sessions by the research units
Method of measurement
General Health Questionnaire: GHQ, DSES Questionnaire (Daily Spiritual Experiences)
2
Description
Quality of life after childbirth in women with preeclampsia
Timepoint
In two stages before the intervention and 6 weeks after the end of the consultation sessions by the research units
Method of measurement
Postpartum Quality of Life Questionnaire
Intervention groups
1
Description
Intervention group: The intervention group will receive three face-to-face counseling sessions for 45-60 minutes during hospitalization and two sessions of telephone postpartum counseling weekly after discharge. The contents of the sessions include introducing oneself and getting to know the patient, expressing the goals of the project, creating empathy, talking about the disease, assessing the mental condition and physical condition, paying attention to the patient's attitude towards the disease, physical health, negative emotions, stress and worries and strategies to deal with them. About the concept of quality of life, dimensions of quality of life and the importance of self-awareness, belief, values in life. Talking about one's expectations of life, community, values, attitude towards spiritual issues, the role of God and religion in life Talk about Positive experiences of the patient about the use of spiritual issues in dealing with stressful situations in life Recalling the role of women in creation, spiritual aspects of pregnancy and childbirth, maternal role from the perspective of Islam, review of the previous session With breathing exercises and repeating it 10 to 15 times a day, it is recommended to listen to the music of nature, the sound of the Quran during the day, the role of charity, trust, recourse, patience, charity (kindness and forgiveness) and focusing on God's blessings in reducing stress. Pre-assessment sessions on a person's mood, attitude and beliefs The role of gratitude to God in enduring hardships, increasing hope and self-confidence in adjustment and accepting the position of the role of reading the Bible in patients' comfort, the story of religious people, encouraging patients to talk to people who make them feel positive, increasing intimacy with spouse Using their participation in life-centered counseling responsibilities in telephone follow-up sessions will include reviewing and recalling the content of face-to-face counseling sessions. Including trust, empathy and honesty between midwives and mothers to communicate properly during the sessions.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Mousavi Hospital in Zanjan
Full name of responsible person
Robab Rasouli
Street address
Gavazang Road
City
zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 1433 8300
Email
robabrasouli1010@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Alireza Shoghli
Street address
Zanjan University of Medical Sciences, Azadi Blvd., Zanjan
City
zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 1433 8300
Email
robabrasouli1010@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Zanjan University of Medical Sciences
Proportion provided by this source
1
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
Zanjan University of Medical Sciences
Full name of responsible person
Robab Rasouli
Position
Master Student of Counseling In Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
دانشگاه علوم پزشکی زنجان، جاده گاوازنگ
City
zanjan
Province
Zanjan
Postal code
4514938017
Phone
+98 24 3373 7751
Email
robabrasouli1010@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Azam Maleki
Position
PhD in Maternal And Child Health
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Zanjan University of Medical Sciences Gavazang Road
City
zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3342 0651
Email
Malekia@zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Azam Maleki
Position
PHD of Maternal and Child Health
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Zanjan University of Medical Sciences Gavazang Road
City
zanjan
Province
Zanjan
Postal code
4515613191
Phone
024334206519
Email
Malekia@zums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD