This trial aims to assess the effect of Lavender cream with or without foot bathduring pregnancy and postpartum on sleep quality and anxiety (primary outcomes) and on depression, stress, fatigue, mother to infant bonding, length of gestation and birth weight (secondary outcomes). 129 women in 25-28 weeks of pregnancy will be allocated into three groups (receiving lavender and footbath, only lavender or only placebo cream) using block randomization with block sizes of 3, 6 and 9 andallocation ratio 1:1:1. A person not involved in sampling and data collection will put the creamsinto sequentially numbered sealed opaque packs to conceal allocation sequence.All subjects will rub the creams on their feet once a day an hour before bedtime.In the first group, the pack will also contain a paper written footbath on it. This group will immerse legs into 40 to 42°c water for 10-20 minutes after using cream. The subjects will discontinue using the creams after 8 weeks and restart it from the first day until 6 weeks postpartum. Footbath would be used with no discontinuation. All subjects will fill Pittsburgh Sleep Quality Index (PSQI) and the Distress, Anxiety and Stress Scale (DASS-21) at 4 and 8 weeks and Multidimensional Assessment of Fatigue (MAF) at 6 weeks after intervention; all the questionnaires at baseline and 6 weeks after delivery, and Postpartum Bonding Questionnaire (PBQ) 6 weeks after delivery. Repeated Measurement and ANCOVA will be used to compare mean score of the outcome variables among the groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201211293706N17
Registration date:2014-04-04, 1393/01/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-04-04, 1393/01/15
Registrant information
Name
Sakineh Mohammad-Alizadeh-Charandabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3477 2699
Email address
alizades@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences (all funds, except the creams), Barij Essence Pharmaceutical company (producing and packing the Lavender and Placebo creams)
Expected recruitment start date
2013-05-05, 1392/02/15
Expected recruitment end date
2013-12-22, 1392/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Lavender cream with or without foot bath during pregnancy and postpartum on sleep quality and anxiety: a randomized controlled trial
Public title
Effect of Lavender cream with or without foot bath during pregnancy and postpartum on sleep quality and anxiety
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: • First to third pregnancy • Gestational age of 25 to 28 weeks • Having a singleton live fetus • Literate • Aged 18 to 45 years • Acquiring Pittsburgh Sleep Quality Index score of 5 or higher. Exclusion criteria: • Having any chronic disease (including diabetes, thyroid disease, preeclampsia, anemia) • Using certain medications • Smoking • History of infertility • Unwanted pregnancy • Allergy to the herbs • Any wounds on the washing and cream rubbing site • Having severe anxiety, depression or stress (Anxiety score above 10, depression score above 14 or stress score above 17 in the DASS-21) • Obesity (BMI above 29) • Having night shift work • No access to phone line.
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
129
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Triple blind only about the intervention II and control groups but not blinded about the interventiongroup III
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research deputy, Tabriz University of Medical Sciences
Street address
3rd floor, 2nd central building, Golgasht street, Tabriz, Iran
City
Tabriz
Postal code
Approval date
2013-01-21, 1391/11/02
Ethics committee reference number
91184
Health conditions studied
1
Description of health condition studied
sleep quality in pregnancy AND postparetum
ICD-10 code
G47.9
ICD-10 code description
Sleep disorder, unspecified
2
Description of health condition studied
Anxiety in pregnancy and postpartum
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
Sleep quality score
Timepoint
Before intervention, 4 and 8 weeks after initiation of intervention and 6 weeks after delivery
Method of measurement
Pittsburgh Sleep Quality Index
2
Description
Anxiety score
Timepoint
At baseline, 4 and 8 weeks after initiation of intervention and 6 weeks after delivery
Method of measurement
DASS-21
Secondary outcomes
1
Description
Length of gestation
Timepoint
After delivery
Method of measurement
Using the LMP or resulu of Ultrasound done before 12 weeks of pregnancy and birth date
2
Description
Birth weight
Timepoint
After delivery
Method of measurement
Weight recorded in the newborn discharge card
3
Description
Fatigue Score
Timepoint
At baseline, 6 weeks after intervention and 6 weeks after delivery
Method of measurement
Multidimensional Assesment o Fatigue scale (MAF)
4
Description
Score of Stress
Timepoint
At baseline, 4 and 8 weeks after intervention and 6 weeks after delivery
Method of measurement
DASS-21
5
Description
Score of Depression
Timepoint
At baseline, 4 and 8 weeks after intervention and 6 weeks after delivery
Method of measurement
DASS-21
6
Description
Score of mother and infant bonding
Timepoint
Six weeks after delivery
Method of measurement
Postpartum Bonding Questionnaire (PBQ)
Intervention groups
1
Description
Intervention groupI: The participants will rub Lavender creamon their feet once a day about 1 hour before bedtime for the first 8 weeks, as well as for 6 weeks postpartum; they will also immerse legs in 40 to 42 °c water to a depth of 5 cm above the ankle for 10-20 minutes for 8 weeks and will be recommended to continue it until 6 weeks postpartum, if they like.
Category
Treatment - Drugs
2
Description
Intervention groupII: The participants will rub Lavender cream on their feet once a day about an hour before bedtime for the first 8 weeks, as well as for 6 weeks postpartum.
Category
Treatment - Drugs
3
Description
Control group: The participants will get no intervention but will get routine care and instructions like the other groups
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Selected public health centers and health posts in Tabriz
Full name of responsible person
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research deputy of Tabriz university of medical sciences
Full name of responsible person
Dr. Kazem Shakouri
Street address
Golgasht st.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research deputy of Tabriz university of medical sciences
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Barij Essence Pharmaceutical Company
Full name of responsible person
Dr. Mohsen Tagizadeh
Street address
Mashade Ardehal- Kashan- PO.Box 1178
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Barij Essence Pharmaceutical Company
Proportion provided by this source
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
Faculty of Nursing & Midwifery- Tabriz University of Medical Sciences
Full name of responsible person
Fatemeh Effati Daryani
Position
MSc student in midwifery
Other areas of specialty/work
Street address
Kousar Dormitory, South Shariati Ave, Tabriz, Iran
City
Tabriz
Postal code
Phone
+98 44 1225 2309
Fax
Email
mahta0608@yahoo.com , effati_f@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences
Full name of responsible person
Sakineh Mohammad-Alizadeh-Charandabi
Position
Assistant professor, PhD in Reproductive Health
Other areas of specialty/work
Street address
Midwifery Department, Faculty of Nursing and Midwifery,South Shariati, Tabriz, Post Code: 5138947977, P.O.Box: 51745-347
City
Tabriz
Postal code
Phone
+98 41 1477 2699
Fax
+98 41 1479 6969
Email
alizades@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences
Full name of responsible person
Sakineh Mohammad-Alizadeh-Charandabi
Position
Associate professor, PhD in Reproductive Health
Other areas of specialty/work
Street address
Midwifery Department, Faculty of Nursing and Midwifery,South Shariati, Tabriz, Post Code: 5138947977, P.O.Box: 51745-347
City
Tabriz
Postal code
Phone
+98 41 1477 2699
Fax
+98 41 1479 6969
Email
alizades@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)