1
Clinical Trial Protocol
Iranian Registry of Clinical Trials
05 Nov 2022
The effect of orange peel essential oil on postpartum anxiety and depression : a randomized controlled trial
Protocol summary
Summary
Objectives: This study aims to determine the effect of orange peel essential oil on postpartum anxiety and depression. Design: A double blind randomized control trial. Setting and conduct: This study will be conducted on 96 nulliparous and multiparous women who hospitalized at postpartum ward in Alzahra, Taleghani and 29 Bahman hospitals. Eligible women will be assigned randomly into three groups of 33 subjects with block sizes of 4 and 6. A person from research team not involved in the recruitment and assigning participants will generate allocation sequence using a computerized program. Opaque sealed sequentially numbered envelops will be used for allocation concealment.
Participants will be assessed by researcher in terms of eligibility criteria. Then, Eligible women will complete Edinburg depression scale. If they will get score lower than 12; the Spilberger anxiety scale and demographic questionnaire will be completed by them. Participants including major eligibility criteria: Women with ages 18 years and higher who hospitalized at postpartum ward.
Interventions: The intervention group will receive orange peel essential oil, 10 drops oral 3 times a day for eight weeks and the control group will receive placebo essential oil 10 drops 3 times daily for 8 weeks. Main outcome measures: The anxiety and depression scores will be evaluated before intervention and 8 weeks after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number: IRCT2014101210324N21 Registration date: 2014-12-30, 1393/10/09
Registration timing: registered_while_recruiting Last update:
Update count: 0 Registration date
2014-12-30, 1393/10/09 Registrant information
Name
Mojgan Mirghafourvand Name of organization / entity
Tabriz University of Medical Sciences Country
Iran (Islamic Republic of) Phone
+98 41 1479 6969 Email address
mirghafourvandm@tbzmed.ac.ir Recruitment status
Recruitment complete Funding source
Research Department of Tabriz University of Medical Sciences
Expected recruitment start date 2014-11-19, 1393/08/28
Expected recruitment end date 2015-03-19, 1393/12/28 Actual recruitment start date
empty
Actual recruitment end date empty
Trial completion date empty
Scientific title
The effect of orange peel essential oil on postpartum anxiety and depression : a randomized controlled trial Public title
The effect of orange peel essential oil on postpartum anxiety and depression
Purpose Prevention
2 Inclusion/Exclusion criteria
Inclusion criteria: 18 years and older women; Residence in Tabriz city; Having literacy; Women delivered at 48 hours ago (nulliparous or multiparous); Vaginal or cesarean delivery; Having a low-risk pregnancy;
Willingness to participate in the study; Having care record in nearest health center; Having the home telephone or mobile number; Getting score lower than 12 according to Edinburg scale. Exclusion criteria: Having depression disorder before delivery according to self- expression; Neonatal death or neonate bedridden in Neonatal Intensive Care Unit (NICU); Stillbirth; Mothers who bedridden for postpartum complications; Having a bad event at three month ago such as death or hospitalization of a family member; Having chronic disease such as liver or kidney disease; Having repeated abortion
Age
From 18 years old to 45 years old Gender
Female Phase
2-3
Groups that have been masked No information
Sample size
Target sample size: 96
Randomization (investigator's opinion) Randomized
Randomization description Blinding (investigator's opinion)
Triple blinded Blinding description Placebo
Used Assignment
Parallel
Other design features
Secondary Ids empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Research Department of Tabriz University of Medical Sciences, Tabriz, Mohammad Reza Rashidi, Liberty Street, St. Golgasht, Tabriz University of Medical Sciences, Central Building No. 2, Third Floor, Research Department of Tabriz
City Tabriz Postal code Approval date
2014-10-20, 1393/07/28
Ethics committee reference number 93114
Health conditions studied
1
Description of health condition studied anxiety and depression
ICD-10 code F41.2
ICD-10 code description
Mixed anxiety and depressive disorder
Primary outcomes
1
Description Depression Timepoint
Before intervention and eight weeks after intervention Method of measurement
Edinburg questionnaire
2
Description Anxiety Timepoint
Before intervention and eight weeks after intervention Method of measurement
Spilberger questionnaire
Secondary outcomes
1
Description
Patients satisfaction level from treatment Timepoint
During eight weeks of intervention Method of measurement
Questionnaire
2
Description
Frequency of side events of drug Timepoint
During eight weeks of intervention Method of measurement
Side event questionnaire
Intervention groups
1
Description
The intervention group will receive orange peel essential oil,10 drops oral 3 times a day for eight weeks.
3 Category
Treatment - Drugs
2
Description
The control group will receive placebo including Propylene glycol and water 10 drops 3 times daily for 8 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center Taleghani hospital
Full name of responsible person Mina Galeshi
Street address
Nursing & Midwifery Faculty, South Shariati Street City
Tabriz
2
Recruitment center
Name of recruitment center Alzahra hospital
Full name of responsible person Mina Galeshi
Street address
Nursing & Midwifery Faculty, South Shariati Street City
Tabriz
3
Recruitment center
Name of recruitment center 29 bahman hospital
Full name of responsible person Mina Galeshi
Street address
Nursing & Midwifery Faculty, South Shariati Street City
Tabriz
Sponsors / Funding sources
1 Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person Rashidi Mohammad Reza Street address
Research department, third floor, central construction
number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz, and East Azerbaijan
City Tabriz Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tabriz University of Medical Sciences
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 Tabriz University of Medical Sciences Full name of responsible person
Mina Galeshi Position
MSc student in Midwifery Other areas of specialty/work Street address
Nursing & Midwifery Faculty, South Shariati Street City
Tabriz Postal code
5138947977 Phone
+98 41 3479 6770 Fax
galeshi_m@yahoo.com Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity Tabriz University of Medical Sciences Full name of responsible person
Dr. Mojgan Mirghafourvand Position
PhD of Reproductive Health Other areas of specialty/work Street address
Nursing & Midwifery Faculty, South Shariati Street City
4 Tabriz
Postal code 5138947977 Phone
+98 41 3479 6770 Fax
Mirghafourvandm@tbzmed.ac.ir;
mirg1385@yahoo.com Web page address
http://nursing.tbzmed.ac.ir
Person responsible for updating data
Contact
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
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