Protocol summary

Study aim
Determining the effect of maternal holding and massage on heel blood sampling, physiological responses, and pain in neonates
Design
The study included three groups that had two intervention groups and one control group. An intervention group is the mother's embrace which the baby is considered to be in the mother's arms. A massage group that deals with the massage of the baby's leg. And the control group that receives the usual interventions of the health center. The study included a sample of 135 infants aged 38 to 42 weeks. Sampling and interventions are carried out at Bandar Abbas Health Center. The samples were allocated to​ intervention and control groups according to the day of referral to the health center and there was no randomization in the selection of samples.
Settings and conduct
Sampling and interventions are carried out at Bandar Abbas Health Center. The samples were allocated to intervention and control groups according to the day of referral to the health center and there was no randomization in the selection of samples.
Participants/Inclusion and exclusion criteria
Healthy full-term infants (38 to 42 weeks) Birth weight 2500-4000 grams Apgar more than 7 at birth. Stability in terms of clinical condition Stable in terms of clinical condition infants at 4th to 6th birthday who to screen for hypothyroidism.
Intervention groups
Intervention group: In the mother's embrace group, the infants are placed in their mother's arms two minutes before, during and at least 15 seconds after blood sampling, with the difference that they are not breastfed. All infants will be awake when applying this procedure. Their mothers sit on the comfort seat and will be allowed to cuddle their babies when they cry during blood sampling. In the massage group before blood sampling, the researcher gently massages the baby's foot from the fingertips to the middle of the thigh, massage with the effleurage technique will be done with the thumb of one hand for 2 minutes, and the place of massages will be covered for one minute with a warm towel. Massage is used to move the contents of the superficial lymph vessels and blood vessels to facilitate blood circulation as well as to manipulate tissue fluids. The effleurage is done through the flow direction of venous to the heart. Massage is soft, smooth, uniform and constant, and always from the point of return of the vessels (distal) to the primary areas (proximal). In the control group, the routine procedure of the health center (sleeping on the bed during blood sampling) is performed. It should be noted that all blood sampling is carried out under the same conditions with the same facilities and by one of the health center personnel.
Main outcome variables
Pain, crying time, physiological indices (heart rate, respiration, oxygen saturation)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170116031972N4
Registration date: 2018-02-27, 1396/12/08
Registration timing: retrospective

Last update: 2018-02-27, 1396/12/08
Update count: 0
Registration date
2018-02-27, 1396/12/08
Registrant information
Name
Mahlagha Dehghan Anari
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5201
Email address
m_dehghan@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2017-07-22, 1396/04/31
Actual recruitment start date
2017-05-22, 1396/03/01
Actual recruitment end date
2017-07-22, 1396/04/31
Trial completion date
empty
Scientific title
Comparative effect of maternal holding and massage on heel blood sampling, physiological responses, and pain in neonates
Public title
Comparative effect of maternal holding and massage on heel blood sampling, physiological responses, and pain in neonates
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy full-term infants (38 to 42 weeks) Birth weight 2500-4000 grams Apgar more than 7 at birth. Stability in terms of clinical condition infants at 4th to 6th birthday who to screen for hypothyroidism.
Exclusion criteria:
Having any congenital and chromosomal anomalies Having painful interventions such as circumcision and getting the peripheral vein before referring to the health center
Age
From 266 days old to 294 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 135
Actual sample size reached: 135
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Kerman University of Medical Sciences
Street address
Ebnesina St،Jahad Blvd، Somaye Crossroad، Kerman
City
Kerman
Province
Kerman
Postal code
7815789957
Approval date
2017-04-04, 1396/01/15
Ethics committee reference number
Ir.kmu.rec.1395.998

Health conditions studied

1

Description of health condition studied
Pain, crying time due to blood sampling, physiological symptoms (heart rate, respiration rate, and oxygen saturation)
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The initial outcome could be an increase or decrease in the pain score
Timepoint
The pain score measurement is done at the beginning of the study (before the intervention), immediately after blood sampling, and 5 minutes after blood sampling
Method of measurement
Neonatal Infant Pain Scale (NIPS)

2

Description
The initial outcome could be an increase or decrease in the baby's crying time
Timepoint
The time interval for the measurement of the crying time is after blood sampling
Method of measurement
Stop watch

Secondary outcomes

1

Description
The initial outcome could be an increase or decrease in the heart rate
Timepoint
Heart rate measurement as a secondary outcome is done at the beginning of the study (before the intervention), immediately after blood sampling, and 5 minutes after blood sampling
Method of measurement
Pulse Oximeter

2

Description
The initial outcome could be an increase or decrease in SPO2
Timepoint
SPO2 measurement as a secondary outcome is​ done at the beginning of the study (before the intervention), immediately after blood sampling, and 5 minutes after blood sampling
Method of measurement
Pulse Oximeter

3

Description
The initial outcome could be an increase or decrease in respiratory rate
Timepoint
Respiratory rate measurement as a secondary outcome is done at the beginning of the study (before the intervention), immediately after blood sampling, and 5 minutes after blood sampling
Method of measurement
Pulse Oximeter

Intervention groups

1

Description
Intervention group: In the mother's embrace group, the infants are placed in their mother's arms two minutes before, during and at least 15 seconds after blood sampling, with the difference that they are not breastfed. All infants will be awake when applying this procedure. Their mothers sit on the comfort seat and will be allowed to cuddle their babies when they cry during blood sampling.
Category
Other

2

Description
Intervention group: In the massage group before blood sampling, the researcher gently massages the baby's foot from the fingertips to the middle of the thigh, massage with the effleurage technique will be done with the thumb of one hand for 2 minutes, and the place of massages will be covered for one minute with a warm towel. Massage is used to move the contents of the superficial lymph vessels and blood vessels to facilitate blood circulation as well as to manipulate tissue fluids. The effleurage is done through the flow direction of venous to the heart. Massage is soft, smooth, uniform and constant, and always from the point of return of the vessels (distal) to the primary areas (proximal).
Category
Other

3

Description
Control group: In the control group, the routine procedure of the health center (sleeping on the bed during blood sampling) is performed. It should be noted that all blood sampling is carried out under the same conditions with the same facilities and by one of the health center personnel.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Tohid Health Center
Full name of responsible person
Zahra Aliyas
Street address
Tohid Town, Bandar Abbas, Hormozgan
City
Bandar Abbas
Province
Hormozgan
Postal code
7919633845
Phone
+98 76 3370 6373
Email
zahraaliyas@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhti
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3226 3855
Email
vcr@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Atefe Roshanray
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Hormozgan, Bandar Abbas, Tohid Town
City
Bandar Abbas
Province
Hormozgan
Postal code
7616913555
Phone
+98 76 3366 6240
Email
Roshanray375@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Masood Rayani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman,
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Fax
Email
m_rayani@kmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Atefe Roshanray
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Hormozgan, Bandar Abbas, Tohid Town
City
Bandar Abbas
Province
Hormozgan
Postal code
7616913555
Phone
+98 76 3366 6240
Email
Roshanray375@gmail.com

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
There is still no plan to develop a program for sharing the data. According to the above sampling data time, the study will be completed by that time.
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
No - There is not 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
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