The effect of cognitive-behavioral counseling with/without Neroli essence on sleep quality of pregnant women
Design
Randomized controlled trial with three parallel arms
Settings and conduct
This trial will be performed on 75 pregnant women who referring to health centers of Tabriz. Pregnant women will be assessed according to the eligibility criteria and if they have criteria and willingness to participate in the study, the written informed consent will obtained and primary evaluations will be conducted. Participants will be assigned to the three groups including: Intervention group 1: Recipient of cognitive-behavioral counseling and placebo of Neroli essence, Second intervention group: Recipient of cognitive-behavioral counseling with aromatherapy with Neroli essence and control group by the block randomization method.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Pregnant women with a gestational age of 20 to 24 weeks, Women with poor sleep quality based on the Pittsburgh Sleep Quality Questionnaire (score above 5)
Exclusion criteria: Pregnant mothers with mental illnesses and a history of hospitalization in a psychiatric hospital and the use of any psychological medication based on the individual expression, Mothers with drug and smoking addiction according to the individual expression.
Intervention groups
The first intervention group: the recipient of cognitive-behavioral counseling and placebo of Neroli essence; The second intervention group: the recipient of cognitive-behavioral counseling with aromatherapy with Neroli essence and the control group: the recipient of routine care.
Main outcome variables
Sleep quality of pregnant women
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120718010324N63
Registration date:2021-02-13, 1399/11/25
Registration timing:registered_while_recruiting
Last update:2021-02-13, 1399/11/25
Update count:0
Registration date
2021-02-13, 1399/11/25
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
Expected recruitment start date
2021-01-08, 1399/10/19
Expected recruitment end date
2021-05-19, 1400/02/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cognitive-behavioral counseling with/without Neroli essence on sleep quality of pregnant women: a randomised controlled trial
Public title
The effect of cognitive-behavioral counseling on sleep quality of pregnant women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women with a gestational age of 20 to 24 weeks
Women with poor sleep quality based on the Pittsburgh Sleep Quality Questionnaire (score above 5)
Has a minimum secondary education degree
Living in Tabriz
Pregnant women with a file in the health center (Sib system)
No olfactory problems and sensitivity to herbal medicines according to the patient's report
Achieving a depression score of 12 or lower based on the Edinburgh Depression Inventory
Exclusion criteria:
Pregnant mothers with mental illnesses and a history of hospitalization in a psychiatric hospital and the use of any psychological medication based on the individual expression
Mothers addicted to drugs and cigarettes according to the individual expression
Mothers with high-risk pregnancies, including diabetes, high blood pressure, chronic diseases affecting pregnancy, such as cardiovascular, lung and ....
Mothers with obstetrics problems including bleeding, history of preterm delivery and ...
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be assigned to the three groups including: Intervention group 1: Recipient of cognitive-behavioral counseling and placebo of Neroli essence, Second intervention group: Recipient of cognitive-behavioral counseling with aromatherapy with Neroli essence and control group by the block randomization method with block sizes of 6 and 9 and with a 1: 1: 1 allocation ratio. In order to hide the allocation (Allocation Concealment), the type of intervention is written on paper and sealed in opaque envelopes. The envelopes will be opened in order of the participants entering the study and the type of group will be determined. Random allocation and preparation of envelopes will be done by a person not involved in sampling and data collection.
Blinding (investigator's opinion)
Not 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
Reaserch department, third floor, central construction number 2, Tabriz university of medical sciences, Golgasht street, Azadi avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Approval date
2020-12-29, 1399/10/09
Ethics committee reference number
IR.TBZMED.REC.1399.905
Health conditions studied
1
Description of health condition studied
Sleep quality
ICD-10 code
G47.9
ICD-10 code description
Sleep disorder, unspecified
Primary outcomes
1
Description
Sleep quality
Timepoint
Immediately and four weeks after the intervention
Method of measurement
Pittsburgh Sleep Quality Questionnaire
Secondary outcomes
1
Description
Anxiety
Timepoint
Immediately and four weeks after the intervention
Method of measurement
Pregnancy Anxiety Questionnaire
2
Description
Quality of life
Timepoint
Immediately and four weeks after the intervention
Method of measurement
Quality of Life Questionnaire
Intervention groups
1
Description
The first intervention group will receive cognitive-behavioral counseling and placebo of Neroli essence. Counseling will be provided in 8 group sessions in native language. The average duration of counseling sessions will be 60 to 90 minutes. Also, 2 drops of placebo of Neroli essence will be inhaled by the participants for 15-20 minutes before going to bed. The protocol of cognitive-behavioral counseling approach will be as follows: Session 1: Explaining the goals of training and acquaintance with members, conducting a pre-test, teaching how to monitor the baseline of sleep with a sleep report table, reminding the importance of treatment tasks, a complete assessment of the nature of insomnia; Session 2: Presenting the principles and logic of treatment, teaching the mechanism of sleep and its stages, sleep-wake cycles, predisposing, maintenance and persistence factors of insomnia, relaxation education; Session 3: Reviewing the previous treatment session, assessing the findings of the sleep report form, sleep hygiene training, and reviewing the relaxation and new sleep schedule; Session 4: Restricting sleep, preventing daily naps, evaluating thoughts and teaching how to record thoughts related to insomnia, reviewing and assessing the assignments of previous sessions (sleep report form and homework assignment); Session 5: Summarizing thoughts, problem solving skills, reviewing the sleep report form and homework assignments and troubleshooting; Session 6: Introduce the cycle of thinking, feeling and behavior, reviewing the relaxation and teaching not to try in vain to fall asleep and apply all the instructions of the previous sessions and reviewing the homework of the previous sessions (sleep report form and homework assignments); Session 7: Training the thought blocking, mental imaging, troubleshooting about cognitive-behavioral therapy plan, reviewing the patient's homework; Session 8: Reviewing and troubleshooting the cognitive-behavioral treatment plan, noting the progress of treatment according to the sleep calendar.
Category
Behavior
2
Description
The second ntervention group will receive cognitive-behavioral counseling and Neroli essence. Counseling will be provided in 8 group sessions in native language. The average duration of counseling sessions will be 60 to 90 minutes. Also, 2 drops of Neroli essence will be inhaled by the participants for 15-20 minutes before going to bed. The protocol of cognitive-behavioral counseling approach will be as follows: Session 1: Explaining the goals of training and acquaintance with members, conducting a pre-test, teaching how to monitor the baseline of sleep with a sleep report table, reminding the importance of treatment tasks, a complete assessment of the nature of insomnia; Session 2: Presenting the principles and logic of treatment, teaching the mechanism of sleep and its stages, sleep-wake cycles, predisposing, maintenance and persistence factors of insomnia, relaxation education; Session 3: Reviewing the previous treatment session, assessing the findings of the sleep report form, sleep hygiene training, and reviewing the relaxation and new sleep schedule; Session 4: Restricting sleep, preventing daily naps, evaluating thoughts and teaching how to record thoughts related to insomnia, reviewing and assessing the assignments of previous sessions (sleep report form and homework assignment); Session 5: Summarizing thoughts, problem solving skills, reviewing the sleep report form and homework assignments and troubleshooting; Session 6: Introduce the cycle of thinking, feeling and behavior, reviewing the relaxation and teaching not to try in vain to fall asleep and apply all the instructions of the previous sessions and reviewing the homework of the previous sessions (sleep report form and homework assignments); Session 7: Training the thought blocking, mental imaging, troubleshooting about cognitive-behavioral therapy plan, reviewing the patient's homework; Session 8: Reviewing and troubleshooting the cognitive-behavioral treatment plan, noting the progress of treatment according to the sleep calendar.
Category
Behavior
3
Description
The control group will receive pregnancy routine care.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz city health centers
Full name of responsible person
Narges Rahmani
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
9876065489
Phone
+98 41 3341 4567
Email
nargesrahmani313@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Samiei
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947979
Phone
+98 41 3479 6969
Email
iro@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Narges Rahmani
Position
MSc student of counseling in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5358153561
Phone
+98 41 3341 4567
Email
nargesrahmani313@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mojgan Mirghafourvand
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947979
Phone
+98 41 3177 2048
Email
mirghafourvandm@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mojgan Mirghafourvand
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947979
Phone
+98 41 3177 2048
Email
mirghafourvandm@tbzmed.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
Participant data is confidential
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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