Main purpose: To evaluate the effect of foot massage on sleep quality in postmenopausal women
Specific Objectives: 1- Determining the effect of foot massage on the duration of sleep in postmenopausal women
2- Determining the effect of foot massage on the sleep adequacy of postmenopausal women
3- Determining the effect of foot massage on the mental quality of sleep in postmenopausal women
4- Determining the effect of foot massage on the duration of sleep period of postmenopausal women
Design
Clinical trial with control group, randomized with permutation blocks,on 74 participants
Settings and conduct
Location: Selseh County Health Network
To perform the massage, the participant is asked to lie down in a dark and quiet room in a comfortable position, then place his legs above the body surface by placing a pillow under them so that the participant's legs In front of the massager, then the person doing the massage, after washing his hands and drying them to reduce friction, dip his hands in the lubricant (olive oil) and perform the massage.
Participants/Inclusion and exclusion criteria
Admission requirements: Age 60-45 years - At least one year has passed since the last menstrual period.
Withdrawal conditions: Any physical and mental illness that causes sleep disorders - taking medication and hormone therapy
Intervention groups
The intervention is performed by a family member of a postmenopausal woman. The foot massage is performed in a simple way the night before bed for 30 minutes (15 minutes per foot) every night for 8 weeks. There is no intervention in the control group.
Main outcome variables
sleep quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210824052276N1
Registration date:2021-09-06, 1400/06/15
Registration timing:prospective
Last update:2021-09-06, 1400/06/15
Update count:0
Registration date
2021-09-06, 1400/06/15
Registrant information
Name
Fatemeh Valipouri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3252 3400
Email address
valipouri.f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-28, 1400/07/06
Expected recruitment end date
2022-03-26, 1401/01/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of foot massage on the sleep quality of postmenopausal women.
Public title
The effect of foot massage on sleep quality of postmenopausal women.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
At least one year has passed since the last menstrual period.
Age 45 to 60 years
Having a companion (someone who lives with a participant who can do massage).
Women with a Pizza Leaf Sleep Quality Questionnaire score of 5 or higher (a score of 5 or higher indicates significant sleep disturbance).
Giving informed informed consent
Exclusion criteria:
Any physical or mental illness that interferes with sleep.
Taking medication and hormone therapy
Fractures, infections, wounds and skin diseases of the lower extremities.
Employment in jobs with night shifts.
Age
From 45 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
The assignment of the intervention to individuals is random and by the method of random permutation blocks with random block sizes of 4, 6 and 8 (using the table related to random permutations) with an allocation ratio of 1: 1. The tool for generating random block sequences is blockrand software package in R software environment. Coding is done by a biostatistics expert to set up a random list.
Concealment: The intervention used in this study, according to a randomized list, is assigned by an out-of-study person who is unaware of the research objectives and according to the corresponding codes in the sealed envelopes.
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 Committee of Ahwaz Jundishapur University of Medical Sciences
Street address
Ahvaz - Golestn - Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2021-08-15, 1400/05/24
Ethics committee reference number
IR.AJUMS.REC.1400.312
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 score on the Pittsburgh Questionnaire
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
Pittsburgh Sleep Quality Questionnaire
Secondary outcomes
1
Description
Mental quality of sleep
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
Pittsburgh Sleep Quality Questionnaire
Intervention groups
1
Description
Intervention group: Foot massage increases blood circulation, releases endorphins and, as a result, relieves insomnia. The sole of the foot is done in a simple way at night before going to bed for 30 minutes (15 minutes each foot with olive oil) every night for 8 weeks.
Category
Lifestyle
2
Description
Control group:No intervention is performed in the control group.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Selseleh city health network.
Full name of responsible person
Dr. Karam Hossein Hassanvand
Street address
Alshtar, Ayatollah Boroujerdi Street
City
Aleshtar
Province
Lorestan
Postal code
6135715794
Phone
+98 66 3252 3400
Email
net.aleshtar@lums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mehdi Ahmadi Moghadam
Street address
Ahvaz University City - Vice Chancellor for Research and Technology Ahvaz Jundishapur University of Medical Sciences and Health Services - Ground Floor
City
Ahvaz
Province
Khouzestan
Postal code
15794 61357
Phone
+98 61 3373 8383
Fax
+98 61 3336 1544
Email
ahmadi_m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Ahwaz Jundishapur 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
Ahvaz University of Medical Sciences
Full name of responsible person
Khadijeh Hekmat
Position
science Committee
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Ahvaz - Golestan - Jundishapur University of Medical Sciences - School of Nursing and Midwifery
City
Ahvaz
Province
Khouzestan
Postal code
15794 -61357
Phone
+98 61 3373 8331
Email
Hekmat1346@Gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Khadijeh Hekmat
Position
science Committee
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Ahvaz - Golestan - Jundishapur University of Medical Sciences - School of Nursing and Midwifery
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8331
Email
Hekmat1346@Gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Khadijeh Hekmat
Position
science Committee
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Ahvaz - Golestan - Jundishapur University of Medical Sciences - School of Nursing and Midwifery
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8331
Email
Hekmat1346@Gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Part of the data related to the main outcome is shared.
When the data will become available and for how long
Access period starts 4 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
For use in research work
From where data/document is obtainable
Khadijeh Hekmat
Contact number: 09161117300
Email: Hekmat1346@Gmail.com
Address: Ahvaz - Golestan - Jundishapur University of Medical Sciences - School of Nursing and Midwifery
What processes are involved for a request to access data/document
Request from the responsible executor via email and provide the purpose of data access.