The purpose of this research is to compare the effect of mindfulness-based counseling and aromatherapy with lavender essential oil on the sleep quality of postpartum mothers.
Design
A randomized clinical trial study with two intervention groups and one control group, parallel groups, phase 4, on 132 women who have given birth less than 2 weeks. Randomization was done using SPSS software.
Settings and conduct
A randomized clinical trial was conducted in one of the reference hospitals of Isfahan city in women who gave birth.
Participants/Inclusion and exclusion criteria
Age 20-40 years, absence of postpartum depression and lack of completion of sleep questionnaire
Intervention groups
In this study, 3 لgroups ( intervention 1, intervention 2 and control) participated.. Mindfulness counseling group in the form of 8 one-hour WhatsApp sessions and aromatherapy group with lavender essential oil with a volume of 15 ml, which was poured on a napkin between two drops of this oil overnight for two months. and it is inhaled by people before going to bed for ten minutes.In control group was instructed the routine postpartum care via WhatsApp.
Main outcome variables
The quality of sleep
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220706055397N1
Registration date:2023-07-06, 1402/04/15
Registration timing:retrospective
Last update:2023-07-06, 1402/04/15
Update count:0
Registration date
2023-07-06, 1402/04/15
Registrant information
Name
Zahra Ghalgar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3230 3267
Email address
zahra.ghalgar.74@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-31, 1401/03/10
Expected recruitment end date
2022-09-09, 1401/06/18
Actual recruitment start date
2022-06-10, 1401/03/20
Actual recruitment end date
2022-11-11, 1401/08/20
Trial completion date
2023-02-10, 1401/11/21
Scientific title
Comparison the Effect of Mindfulness Therapy and Aromatherapy with Lavender Essential Oil on Quality of Sleep in Post-Partum Women
Public title
Comparison the Effect of Mindfulness Therapy and Aromatherapy with Lavender Essential Oil on Quality of Sleep in Post-Partum Women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Mothers who passed no more than 2 weeks since their delivery
Pittsburgh Sleep Questionnaire score above 5
Not using complementary medicine or psychological counseling during the last six months
Lack of underlying disease
Lack of pulmonary and respiratory problems such as asthma
Having minimum level of reading and writing literacy and mastering the WhatsApp application
Access to the Internet and WhatsApp application
Exclusion criteria:
Use of complementary medicine or psychological counseling during the past six months
The presence of an underlying disease
The presence of lung and breathing problems such as asthma
Mother's lack of interest in participating in the research
The presence of any problems in the postpartum process, such as the mother or baby being unwell and losing the family
Discomfort and dissatisfaction with the smell of fragrances
Allergy to lavender
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
132
Actual sample size reached:
132
Randomization (investigator's opinion)
Randomized
Randomization description
First, we determine the names and surnames of 132 qualified people who are registered in the above hospital, code them from 1 to 132, and then enter the codes of the people in the SPSS software and use that software. The software that gives us the possibility of simple random selection, we perform a simple random selection and put the subjects under study in each of the groups. For this purpose, after running the random sample of cases, a new column was created in the data whose code 1 indicates the selection for the mindfulness group. Then we delete the selected people of the mindfulness group and execute the command again on other people, and put the code of a new column in the aromatherapy group. The remaining people, who will be coded zero, will be included in the control group.
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 Arak University of Medical Sciences
Street address
Khalige Fars Ave,Arak University of Medical Sciences,Arak town
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2022-05-15, 1401/02/25
Ethics committee reference number
IR.ARAKMU.REC.1401.062
Health conditions studied
1
Description of health condition studied
Postpartum care
ICD-10 code
Z39.2
ICD-10 code description
Encounter for routine postpartum follow-up
Primary outcomes
1
Description
Pittsburgh Sleep Questionnaire score
Timepoint
The sleep score was evaluated at the beginning of the and at the end of the study (8 weeks after the beginning of the study) in 3 groups: mindfulness, aromatherapy with lavender, and the control group.
Method of measurement
Pittsburgh Sleep Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: َ Aromatherapy with lavender with a volume of 15 ml, which is poured on a napkin between two drops of this oil one night for two months, and is inhaled by people for ten minutes before going to bed.
Category
Treatment - Other
2
Description
Intervention group: Mindfulness counseling group in the form of counseling on WhatsApp for 8 one-hour sessions
Category
Treatment - Other
3
Description
Control group: For this group, routine postpartum care, which included breastfeeding, mental health, physical and sexual education, was given by the researcher in a virtual way and in audio and written files. In this group, no counseling was given regarding the improvement of sleep quality.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ascarieh Hospital
Full name of responsible person
Zahra Ghalegar
Street address
Khalige- Fars Ave,Arak University of Medical Science ,Arak
City
Arak
Province
Markazi
Postal code
33848176941
Phone
+98 86 3417 3505
Email
zahra.ghalgar.74@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Zahra Ghalegar
Street address
Khalige- Fars Ave,Arak University of Medical Science ,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3505
Email
zahra.ghalgar.74@gmail.com
Grant name
Grant code / Reference number
6691
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Zahra Ghalegar
Position
Master Science student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Khalije-Fars.Arak university of medical sciences,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3505
Email
zahra.ghalgar.74@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Zahra Ghalegar
Position
Master Science student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Khalije-Fars.Arak university of medical sciences,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3506
Email
zahra.ghalgar.74@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Katayoun Vakilian
Position
Associated professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Khalije-Fars.Arak university of medical sciences,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3508
Email
cattyv2002@yahoo.com
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
We must share with Arak university of medical sciences
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available