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Comparison of the effect of massage and music on the fatigue of mothers of premature infants admitted to the neonatal intensive care unit

Protocol summary

Study aim
Comparison of the effect of massage and music on the fatigue of mothers of premature infants admitted to the neonatal intensive care unit
Design
Random assignment will be done by blocking method. In this block A, the first day of the control phase is performed and on the second day of the music intervention, and on the third day of massage intervention, and B will be done on the first day of the control phase. And on the second day of massage intervention and on the third day of music intervention). In this case, if the number of dice came, the sample would be AABB, if 2 came ABAB, if 3 came BABA, if 4 came ABBA, if 5 came BAAB And if 6 came to be grouped into BBAA.
Settings and conduct
The scope of this research is the neonatal intensive care unit of Valiasr Hospital. The choice of mothers for inclusion in the study is based on entry criteria and according to their entry number, there are a number of interventions A (control, music, massage) or B (control, massage , Music), each row of interventions takes place within three days.
Participants/Inclusion and exclusion criteria
Mothers with infants admitted to infants' care unit, infants from 30 to 37 weeks, newborns with RDS disease, mother's presence for three consecutive days, no history of premature newborns, no hearing problems based on mother's statements, no chronic conditions such as cardiovascular disease , Cancers, nervous and muscular disorders, etc. Having no infectious ulcer at the site of massage.
Intervention groups
The massage group use the Drowning Stroking Wronging. The Music Intervention Group receive the sound of nature, which combines the sounds of rain, river, waterfall and birds, with headphones. The control group relax on the bed.
Main outcome variables
Fatigue in mothers of premature infants

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180626040249N1
Registration date: 2019-01-14, 1397/10/24
Registration timing: retrospective

Last update: 2019-01-14, 1397/10/24
Update count: 0
Registration date
2019-01-14, 1397/10/24
Registrant information
Name
leila abadian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5476 4695
Email address
leyla.abadian95@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-11, 1397/04/20
Expected recruitment end date
2018-08-11, 1397/05/20
Actual recruitment start date
2018-07-11, 1397/04/20
Actual recruitment end date
2018-08-21, 1397/05/30
Trial completion date
2018-09-05, 1397/06/14
Scientific title
Comparison of the effect of massage and music on the fatigue of mothers of premature infants admitted to the neonatal intensive care unit
Public title
Comparative study on the effect of massage and music on fatigue in mather,s of premature infant in neonatal intensive care unit
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having a newborn admitted to the Neonatal Care Unit Mother's presence for three consecutive days
Exclusion criteria:
Not having a pregnancy history of a premature baby Not having hearing problems based on mothers' statements Not having chronic diseases like cardiovascular disease, cancers, nervous and muscular disorders Not having an infective wound on the site of massage
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 41
Actual sample size reached: 41
Randomization (investigator's opinion)
Randomized
Randomization description
Research units will be entered into the research according to the criteria for access to research. Random assignment will be done by blocking method. In this block A means (on the first day of the control phase and on the second day of music intervention and on the third day of massage intervention) and B will be done (on the first day of the control phase) On the second day of the massage, the massage will be performed on the third day of the music intervention). With each throw of dice and the arrival of a number on a dice, the rows of four moms are identified. If the number of dice 1 came in the sample as AABB, if 2 came ABAB, if 3 came BABA, if 4 came ABBA, if 5 came BAAB and if 6 came BBAA grouped.
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 Nursing and Midwifery & Rehabilitation _ Tehran University of Medical Science.
Street address
Tohid Square, Dr Mirkhani Avenue (Eastern Nusrat)
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2018-06-13, 1397/03/23
Ethics committee reference number
IR.TUMS.FNM.REC.1397.011

Health conditions studied

1

Description of health condition studied
Fatigue
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Fatigue score in multi-dimensional fatigue Inventory
Timepoint
15 minutes before the intervention and 15 minutes after intervention, massage and music and control
Method of measurement
To measure fatigue, mothers are asked to use the Multidimensional Fatigue Inventory (MFI). This questionnaire, by assessing 5 dimensions, provides a deeper and more accurate understanding of the person's fatigue. In the MFI fatigue questionnaire, the fatigue of individuals is also measured in the physical dimension in the psychological dimension. For this reason, this questionnaire is preferred to other existing fatigue questionnaires. This tool has 20 questions and it has 5 areas: general fatigue (4 items), physical exhaustion (4 items), mental fatigue (4 items), activity fatigue (4 items), and motivation decrease (4 items).

Secondary outcomes

empty

Intervention groups

1

Description
Since the study design is cross-type, both groups receive the desired interventions in a different order. After the mothers are divided into two groups using block randomization method. Group one: For the first group, baseline, music and massage are performed in three consecutive days (one intervention per day). At the control stage (the first day), the mothers first fill the fatigue questionnaire, then rest for 20 minutes on the bed and complete the fatigue questionnaire 15 minutes after the rest. At the music stage (the second day), the mothers first fill the fatigue questionnaire, then for 20 minutes, the sound of nature (the combination of the sounds of rain, river, waterfall and birds) is played out through the headphones for 20 minutes, and 15 minutes after the completion of the music, the fatigue questionnaire Mothers complete.It should be noted that the amount of sound is adjusted according to the mother and also, to prevent the transmission of infection (due to the use of headphones), after each use, headphones are disinfected.At the massage stage (third day), the mothers first fill the fatigue questionnaire. Then they were fitted with a comfortable and comfortable dressing on the bed. In order to create relaxation and massage, two methods of stroke massage (including percolation and stroke surface and deep) And Rolling.In the massage, the stroke of the palm of the hand is placed on the tissue in the organs and the back of the patient, and is applied to the lymphatic drainage path to a superficial and deep pressure without going into the bony mass points. In Rolling Massage, the muscle tissue is placed in rolls between the thumb and the mark in different places and moves. Rolling on the skin and muscles can affect relaxation.In the ringing massage, the muscle tissue between the thumb and the mark (between both hands) will move in opposite directions; each move will be three to five times, and the massage time will be 20 minutes. 15 minutes after completion of massage, the fatigue questionnaire was completed again by the mothers.
Category
Other

2

Description
Group 2: For the second group, the steps of control, massage and music are performed in three consecutive days (one intervention per day).At the control stage (the first day), the mothers first fill the fatigue questionnaire, then rest for 20 minutes on the bed and complete the fatigue questionnaire 15 minutes after the rest.At the massage stage (tht second day), the mothers first fill the fatigue questionnaire. Then they were fitted with a comfortable and comfortable dressing on the bed. In order to create relaxation and massage, two methods of stroke massage (including percolation and stroke surface and deep) And Rolling.In the massage, the stroke of the palm of the hand is placed on the tissue in the organs and the back of the patient, and is applied to the lymphatic drainage path to a superficial and deep pressure without going into the bony mass points. In Rolling Massage, the muscle tissue is placed in rolls between the thumb and the mark in different places and moves. Rolling on the skin and muscles can affect relaxation.In the ringing massage, the muscle tissue between the thumb and the mark (between both hands) will move in opposite directions; each move will be three to five times, and the massage time will be 20 minutes. 15 minutes after completion of massage, the fatigue questionnaire was completed again by the mothers.At the music stage (third day), the mothers first fill the fatigue questionnaire, then for 20 minutes, the sound of nature (the combination of the sounds of rain, river, waterfall and birds) is played out through the headphones for 20 minutes, and 15 minutes after the completion of the music, the fatigue questionnaire Mothers complete.It should be noted that the amount of sound is adjusted according to the mother and also, to prevent the transmission of infection (due to the use of headphones), after each use, headphones are disinfected.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Batul Pour Aboli Sharaf Abadi
Street address
End of keshavarz Blvd. Imam Khomeini Hospital Complex
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1631
Email
hosp_valiasr@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sayed Ahmad Rezai
Street address
Keshavarz Blvd, Ghods St, Central Organization of the University, Sixth Department of Research and Technology
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 4061
Fax
+98 21 8163 3654
Email
rcco@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
medical University Tehran
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
Tehran University of Medical Sciences
Full name of responsible person
Leila Abadian
Position
Student Master
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Tavid Square, Dr Mirkhani St. (Eastern Nusrat)
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
+98 21 6690 4252
Email
leyla.abadian95@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Batuol Pur Aboli Sharaf Abadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Tavid Square, Dr Mirkhani St. (Eastern Nusrat)
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4411
Fax
+98 21 6690 4252
Email
b_pouraboli@sina.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Leila Abadaian
Position
Student Master
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Tohid Square, Street doctor Myrkhany (N. Eastern), School of Nursing and Midwifery, Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
+98 21 6690 4252
Email
leyla.abadian95@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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