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Comparative of the Effect of Gentle Human Touch Versus Sucrose on Orogastric Tube Insertion Pain and Distress in Preterm Infant Admitted to Neonatal Intensive Care Units: A randomized clinical trial

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History
# Registration date Revision Id
2 2023-09-30, 1402/07/08 281646
1 2023-04-06, 1402/01/17 260733
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  • Protocol summary

    The setting is NICU in Tehran. After selecting the samples, demographic data will be recorded from the baby's medical record. the babies will be placed once as a control group and twice as intervention groups and how to receive interventions will be done using computer randomization. The values of heart rate and oxygen saturation will be recorded 5 minutes before the procedure from the monitor to calculate the pain. Regarding scoring the distress of the baby, it will be calculated using the Neo comfort tool. In the first intervention group, gentle human touch will be performed for 15 minutes. In the sucrose group, 5 minutes before the intervention, the infant's pain score is calculated. 2 minutes after the procedure, heart rate and oxygen saturation values will be recorded, and the baby's pain score will be calculated. Also, 30 seconds after the procedure, the baby's distress score will be calculated.
    The setting is NICU in Tehran. After selecting the samples, demographic data will be recorded from the baby's medical record. the babies will be placed once as a control group and twice as intervention groups and how to receive interventions will be done using computer randomization. The values of heart rate and oxygen saturation will be recorded 5 minutes before the procedure from the monitor. Regarding scoring the distress , it will be calculated using the Neo comfort tool. In the first intervention group, GHT will be performed for 15 minutes. In the sucrose group, 5 minutes before the intervention, the infant's pain score is calculated. Immediately after the intervention and 2 minutes after the procedure, heart rate and oxygen saturation values will be recorded, and the baby's pain score will be calculated. Also, 30 seconds after the procedure, the baby's distress score will be calculated.
    محل انجام این پژوهش بخش NICU در تهران می باشد. پس از انتخاب نمونه ها، داده های دموگرافیک از پرونده پزشکی نوزاد ثبت خواهد شد. سپس نوزادان یک بار به عنوان نمونه گروه کنترل و دو بار به عنوان گروه های آزمون قرار خواهند گرفت که با استفاده از تصادفی سازی کامپیوتری خواهد شد. مقادیر ضربان قلب و اشباع اکسیژن 5 دقیقه قبل از انجام پروسیجر از روی مانیتور متصل به نوزاد، برای محاسبه درد ثبت خواهد شد. در مورد نمره دهی به دیسترس نوزاد بعد از محاسبه نمره درد، با استفاده از ابزار راحتی نئو محاسبه خواهد شد. درگروه مداخله اول، لمس ملایم انسانی به مدت 15 دقیقه انجام خواهد شد. در گروه ساکاروز 5 دقیقه قبل از مداخله، نمره درد نوزاد محاسبه می گردد. 2 دقیقه بعد از انجام پروسیجر مجددا مقادیر ضربان قلب و اشباع اکسیژن ثبت خواهد شد و نمره درد نوزاد محاسبه می گردد. همچنین 30 ثانیه بعد از انجام پروسیجر نمره دیسترس نوزاد محاسبه خواهد شد.
    محل انجام این پژوهش بخش NICU در تهران می باشد. پس از انتخاب نمونه ها، داده های دموگرافیک از پرونده پزشکی نوزاد ثبت خواهد شد. سپس نوزادان یک بار به عنوان نمونه گروه کنترل و دو بار به عنوان گروه های آزمون قرار خواهند گرفت که با استفاده از تصادفی سازی کامپیوتری خواهد شد. مقادیر ضربان قلب و اشباع اکسیژن 5 دقیقه قبل از انجام پروسیجر از روی مانیتور متصل به نوزاد، ثبت خواهد شد. در مورد نمره دهی به دیسترس نوزاد بعد از محاسبه نمره درد، با استفاده از ابزار راحتی نئو محاسبه خواهد شد. درگروه مداخله اول، لمس ملایم انسانی به مدت 15 دقیقه انجام خواهد شد. در گروه ساکاروز 5 دقیقه قبل از مداخله، نمره درد نوزاد محاسبه می گردد. بلافاصله بعد از مداخله و 2 دقیقه بعد از انجام پروسیجر مجددا مقادیر ضربان قلب و اشباع اکسیژن ثبت خواهد شد و نمره درد نوزاد محاسبه می گردد. همچنین 30 ثانیه بعد از انجام پروسیجر نمره دیسترس نوزاد محاسبه خواهد شد.

  • General information

    36
    40
    empty
    40
    empty
    2023-04-22, 1402/02/02
    empty
    2023-09-05, 1402/06/14
    empty
    Completion of study and updating information
    empty
    اتمام مطالعه و بروزرسانی اطلاعات

  • Health conditions studied

    #1
    empty
    G89.11
    empty
    Acute pain due to trauma
    pain
    درد
    #2
    empty
    F45.4
    empty
    The predominant complaint is of persistent, severe, and distressing pain, which cannot be explained fully by a physiological process or a physical disorder, and which occurs in association with emotional conflict or psychosocial problems that are sufficie
    empty
    distress
    empty
    دیسترس

  • Recruitment centers

    #1
    Name of recruitment center - English: hazrat rasol akram hospital
    Name of recruitment center - Persian: بیمارستان حضرت رسول اکرم
    Full name of responsible person - English: mona alinejad naiene
    Full name of responsible person - Persian: منا علی نژاد نائینی
    Street address - English: Hazrat Rasool Akram Hospital, corner of Mansouri St., Niayesh St., Sattar Khan St., Tehran
    Street address - Persian: تهران ، خیابان ستارخان ، خیابان نیایش ، نبش خیابان منصوری ، بیمارستان حضرت رسول اکرم ( ص)
    City - English: tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 02164351000
    Phone: +98 21 6435 1000
    Fax:
    Email: mona_alinejad@yahoo.com
    Web page address:
    Name of recruitment center - English: Hazrat Rasol Akram hospital
    Name of recruitment center - Persian: بیمارستان حضرت رسول اکرم
    Full name of responsible person - English: Mona Alinejad Naiene
    Full name of responsible person - Persian: منا علی نژاد نائینی
    Street address - English: Hazrat Rasool Akram Hospital, corner of Mansouri St., Niayesh St., Sattar Khan St., Tehran
    Street address - Persian: تهران، خیابان ستارخان، خیابان نیایش، نبش خیابان منصوری، بیمارستان حضرت رسول اکرم ( ص)
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 02164351000
    Phone: +98 21 6435 1000
    Fax:
    Email: mona_alinejad@yahoo.com
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: mona alinejad naeine
    Full name of responsible person - Persian: منا علی نژاد نائینی
    Street address - English: School of Nursing and Midwifery, Rashid Yasami St, Vali- e Asr St, Tehran, Iran
    Street address - Persian: میدان ونک- خیابان رشید یاسمی- دانشکده پرستاری مامائی ایران
    City - English: tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: ۱۹۹۶۷۱۳۸۸۳
    Phone: +98 21 4365 1180
    Fax:
    Email: mona_alinejad@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Mona Alinejad Naeine
    Full name of responsible person - Persian: منا علی نژاد نائینی
    Street address - English: School of Nursing and Midwifery, Rashid Yasami St, Vali- e Asr St, Tehran, Iran
    Street address - Persian: میدان ونک، خیابان رشید یاسمی، دانشکده پرستاری مامائی ایران
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: ۱۹۹۶۷۱۳۸۸۳
    Phone: +98 21 4365 1180
    Fax:
    Email: mona_alinejad@yahoo.com
    Web page address:

Protocol summary

Study aim
Comparative of the Effect of Gentle Human Touch Versus Sucrose on Orogastric Tube Insertion Pain and Distress in Preterm Infant
Design
Randomized clinical trial study with www.randomizer.org and cross sectional design with control group with 36 sample.
Settings and conduct
The setting is NICU in Tehran. After selecting the samples, demographic data will be recorded from the baby's medical record. the babies will be placed once as a control group and twice as intervention groups and how to receive interventions will be done using computer randomization. The values of heart rate and oxygen saturation will be recorded 5 minutes before the procedure from the monitor. Regarding scoring the distress , it will be calculated using the Neo comfort tool. In the first intervention group, GHT will be performed for 15 minutes. In the sucrose group, 5 minutes before the intervention, the infant's pain score is calculated. Immediately after the intervention and 2 minutes after the procedure, heart rate and oxygen saturation values will be recorded, and the baby's pain score will be calculated. Also, 30 seconds after the procedure, the baby's distress score will be calculated.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Being hospitalized in the neonatal intensive care unit Fetal age between 29-36 weeks Age after birth 3 to 28 days. Birth weight 1200-3000 grams Order to feed with an oral-gastric tube
Intervention groups
In this study, interventions are (putting in the position of gentle human touch or sucrose). In GHT, the researcher will wash and warm the hands, the baby will be laid on its side, one hand around the baby's head and wrap another hand around the baby's bottom .
Main outcome variables
If any of the methods are effective in reducing the amount of pain and distress of the baby, it can be used as a non-drug method of pain and distress control in babies .

General information

Reason for update
Completion of study and updating information
Acronym
IRCT registration information
IRCT registration number: IRCT20230202057303N1
Registration date: 2023-04-06, 1402/01/17
Registration timing: prospective

Last update: 2023-10-11, 1402/07/19
Update count: 1
Registration date
2023-04-06, 1402/01/17
Registrant information
Name
Mona Alinejad naenie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4365 1180
Email address
mona_alinejad@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
2023-04-22, 1402/02/02
Actual recruitment end date
2023-09-05, 1402/06/14
Trial completion date
empty
Scientific title
Comparative of the Effect of Gentle Human Touch Versus Sucrose on Orogastric Tube Insertion Pain and Distress in Preterm Infant Admitted to Neonatal Intensive Care Units: A randomized clinical trial
Public title
Comparative of the Effect of Gentle Human Touch Versus Sucrose on Orogastric Tube Insertion Pain and Distress in Preterm Infant Admitted to Neonatal Intensive Care Units: A randomized clinical trial
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age between 29-36 weeks Corrected Age after birth 3 to 28 days Birth weight 3000-1200 grams Instructions for feeding with an oral-gastric tube
Exclusion criteria:
Receiving sedatives or anesthetics and muscle relaxants Receive any painkillers in prescription medications Having a skin disease Exposure to any painful procedure at least one hour before intubation Congenital anomalies Metabolic diseases Grade 2 and higher intracranial hemorrhage Cardiac abnormalities History of drug abuse by mother Convulsions
Age
From 29 days old to 36 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Actual sample size reached: 40
Randomization (investigator's opinion)
Randomized
Randomization description
According to the design of this randomized clinical trial study (crossover design), the selected infants will be placed once in the control condition and twice in the intervention conditions (gentle human touch intervention and sucrose intake intervention). The order of placing the nasogastric tube in the usual way and receiving interventions in each baby will be randomly determined. which will be assigned to the desired groups using computer randomization (www.randomizer.org), in such a way that the sequence of placement in the control and intervention conditions will be done randomly. Allocation information will only be available to a researcher.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee's Iran university of medical sciences
Street address
School of Nursing and Midwifery, Rashid Yasami St, Vali- e Asr St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2023-01-01, 1401/10/11
Ethics committee reference number
IR.IUMS.REC.1401.760

Health conditions studied

1

Description of health condition studied
pain
ICD-10 code
G89.11
ICD-10 code description
Acute pain due to trauma

2

Description of health condition studied
distress
ICD-10 code
F45.4
ICD-10 code description
The predominant complaint is of persistent, severe, and distressing pain, which cannot be explained fully by a physiological process or a physical disorder, and which occurs in association with emotional conflict or psychosocial problems that are sufficie

Primary outcomes

1

Description
Pain, Distress
Timepoint
3 days in a row
Method of measurement
The Premature Infant Pain Profile: Revised- Comfort neo scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: gentle human touch, oral sucrose
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Hazrat Rasol Akram hospital
Full name of responsible person
Mona Alinejad Naiene
Street address
Hazrat Rasool Akram Hospital, corner of Mansouri St., Niayesh St., Sattar Khan St., Tehran
City
Tehran
Province
Tehran
Postal code
02164351000
Phone
+98 21 6435 1000
Email
mona_alinejad@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mona Alinejad Naeine
Street address
School of Nursing and Midwifery, Rashid Yasami St, Vali- e Asr St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 21 4365 1180
Email
mona_alinejad@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
iran 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
Iran University of Medical Sciences
Full name of responsible person
Mona Alinejad Naene
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Rashid Yasami St, Vali- e Asr St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 21 4365 1180
Email
mona_alinejad@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mona Alinejad Naeine
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Rashid Yasami St, Vali- e Asr St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 21 4365 1180
Email
mona_alinejad@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mona Alinejad Naeine
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Rashid Yasami St, Vali- e Asr St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 21 4365 1180
Email
mona_alinejad@yahoo.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 no further information
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
No - There is not a plan to make this available
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