Protocol summary

Study aim
Determining the effect of houseplant maintenance on depression, anxiety and quality of life in postpartum women
Design
Clinical trial with control group, with parallel groups, double-blind, randomized using permutation blocking
Settings and conduct
Participants will be randomly divided into two groups. 5 days after delivery, pre-test will be given. The intervention group will be given a geranium pot. Mothers will be asked to take care of the plant for 6 weeks after delivery. Both groups are given a poster of the plants and asked to display the poster in a place 6 weeks after delivery. Then the post-test is performed and compared with the previous one. The blinds will be double-blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: willingness to cooperate in the study; lack of maintenance of houseplants; literacy; gestational age more than 34 weeks; multi parity; no history of cesarean section; women 18 to 45 years old; no fetal abnormalities; no dependence drugs and hookah use in the mother; no history of chronic diseases (such as diabetes, epilepsy, hypertension, heart disease, tuberculosis, previous infertility) according to the mother; no pregnancy complications (such as preeclampsia, placental disorders, cervical insufficiency, gestational diabetes); score less than 12 on the Depression Inventory and less than 31 on the Obvious Anxiety Scale on the Anxiety Pregnancy Questionnaire
Intervention groups
5 days after delivery, the intervention group is given a geranium pot and the necessary training for optimal care of the geranium plant, and mothers are asked to take care of the plant for 6 weeks after delivery. The control group and the intervention group are given a number of posters of plants and are asked to display the poster in a place 6 weeks after delivery.
Main outcome variables
Postpartum depression, anxiety and quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210802052050N1
Registration date: 2021-08-08, 1400/05/17
Registration timing: registered_while_recruiting

Last update: 2021-08-08, 1400/05/17
Update count: 0
Registration date
2021-08-08, 1400/05/17
Registrant information
Name
Faezeh GhafouriMoghadam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 2227
Email address
ghafourimoghaddam.f@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-07, 1400/05/16
Expected recruitment end date
2021-09-07, 1400/06/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of indoor plant care on depression, anxiety and quality of life in postpartum women
Public title
The effect of indoor plant care on depression, anxiety and quality of life in postpartum women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study Being literate Gestational age over 34 weeks Multi parity Women 18 to 45 years old Score less than 12 on the Edinburgh Depression Inventory and score less than 31 on the overt anxiety subscale in the Anxiety Inventory Spiel Burger in pregnancy
Exclusion criteria:
Keeping indoor plants at home History of cesarean section Disorders and abnormalities in the fetus Drug dependence and hookah use in the mother History of chronic diseases (such as diabetes, epilepsy, hypertension, heart disease, tuberculosis, previous infertility) at the mother's own discretion Pregnancy complications (such as preeclampsia, placental disorders, cervical insufficiency, gestational diabetes)
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Investigator
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
For random assignment of samples to each of the 2 intervention and control groups, 4 variable blocks are used. In this way, first 6 possible modes of 4 blocks (BBAA, BABA, ABBA, BAAB AABB, ABAB) are listed and each block is assigned a number from one to 6 using the dice. Then a number between one to 6 is randomly selected and then individuals are assigned to the intervention group (A) and control (B) based on the block corresponding to the selected number. This continues until the sample size is completed.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding will be double-blind in such a way that the person collecting information and questionnaires and the person performing statistical analysis do not know the nature of research in the group (intervention and control).
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Gonabad University of Medical Sciences
Street address
Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9156137374
Approval date
2021-08-02, 1400/05/11
Ethics committee reference number
IR.GMU.REC.1400.056

Health conditions studied

1

Description of health condition studied
Postpartum depression
ICD-10 code
F53
ICD-10 code description
Puerperal psychosis

2

Description of health condition studied
Anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder

Primary outcomes

1

Description
Postpartum depression score
Timepoint
Day 5 after delivery and 6 weeks after delivery
Method of measurement
Edinburgh Depression Inventory

2

Description
Anxiety score
Timepoint
Day 5 after delivery and 6 weeks after delivery
Method of measurement
Spiel Berger Anxiety Inventory

3

Description
Quality of Life
Timepoint
Day 5 after delivery and 6 weeks after delivery
Method of measurement
WHOQOL-BREF

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: the intervention group will be given a geranium pot and the necessary training for optimal care of the geranium plant and a poster of the plants to take care of the plant 6 weeks after delivery.
Category
Lifestyle

2

Description
Control group: to remove the Hawthorne effect, the control group is given a poster of the plants and asked to display the poster in a visible place for 6 weeks after delivery.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Gonabad Health Community Centers
Full name of responsible person
Roghaieh Rahmani_bilondi
Street address
Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9156137374
Phone
+98 51 5722 3028
Email
roghaiehrahmany@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Roghaieh Rahmani
Street address
Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9156137374
Phone
+98 51 5722 3028
Email
info@gmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Roghaieh Rahmani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9156137374
Phone
+98 51 5722 3028
Email
roghaiehrahmany@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Faezeh Ghafouri
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Gonabad University of Medical Sciences, Sento road
City
Gonabad
Province
Razavi Khorasan
Postal code
9156137374
Phone
+98 51 5722 3028
Email
fz.ghafouri@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Faezeh Ghafouri
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Gonabad University of Medical Sciences, Sento road
City
Gonabad
Province
Razavi Khorasan
Postal code
9156137374
Phone
+98 51 5722 3028
Email
fz.ghafouri@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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