1. Home
  2. Approved trials
  3. » فارسی

The effect of Chinese massage on pain caused by gastric tube implantation in premature infants admitted to neonatal intensive care unit: a randomized clinical trial

Protocol summary

Study aim
Determining the effect of Chinese massage on the pain caused by oral-gastric tube placement in premature babies
Design
The total sample size is 62 people Randomized clinical trial by randomized block method with two intervention and control groups with parallel groups Not blinded 31 people in the intervention group and 31 people in the control group
Settings and conduct
Location: special care department for newborns, Imam Khomeini Hospital, Ahvaz. It is not blinded. Intervention: Hugo point massage between two index fingers and thumb, the exact location of which is on the back of the hand, between the first and second metacarpal bones, in the middle of the second metacarpal bone in its axial direction. Methodology: Pain will be measured in three stages before, during and after the intervention by means of the PIPP tool. The time required to observe the baby's behavior is 20 seconds and the behavioral and physiological indicators are 30 seconds.
Participants/Inclusion and exclusion criteria
Inclusion criteria : The gestational age is at least 28 weeks and at most 36 weeks and 6 days weight above 1500 grams Absence of mother's addiction Mother's consent to participate in the study Stability of physiological Exclusion criteria : Refusal of parents to sign the consent form
Intervention groups
In the intervention group, the Hugo point is massaged between the two index fingers and the thumb and on the back of the hand, between the first and second metacarpal bones, in the middle of the second metacarpal bone in its axial direction. The massage is performed in three one-minute sessions with an interval of 30 seconds, 5 minutes before and during the insertion of the oral-gastric tube by the nurse related to the baby. Massage will not be performed in the control group.
Main outcome variables
1- Determining the pain score 2- Determining the amount of physiological and behavioral indicators

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230706058694N1
Registration date: 2023-11-20, 1402/08/29
Registration timing: retrospective

Last update: 2023-11-20, 1402/08/29
Update count: 0
Registration date
2023-11-20, 1402/08/29
Registrant information
Name
ayoub panahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 84 3333 2093
Email address
panahi.a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-13, 1402/04/22
Expected recruitment end date
2023-10-22, 1402/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Chinese massage on pain caused by gastric tube implantation in premature infants admitted to neonatal intensive care unit: a randomized clinical trial
Public title
Investigating the effect of Chinese massage on pain in newborns
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Infants with a gestational age of at least 28 weeks absence of mother's addiction and use of drugs related to epilepsy and neurological disorders willingness and consent of the mother to participate in the study stable clinical and physiological condition of the infant no mechanical ventilation If the baby does not suffer from central nervous system damage he should have an order to fix the nasogastric tube. Failure to receive drugs that affect the physiological and behavioral state not performing any painful procedure at least one hour before the intervention Babies with a gestational age of up to 36 weeks and 6 days
Exclusion criteria:
Significant change in the stability of the hemodynamic state drop in arterial blood oxygen to less than 85% for 2 minutes - sudden death of the baby. early discharge of the baby with the personal consent of the parents
Age
From 7 days old to 9 months old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 62
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we will use the permutation block randomization method. In this two-group clinical trial, the size of the blocks will be 4, 6, and 8 (in this method, the number of people assigned to each group in the blocks is equal). The randomization tool is one of the random sequence generation software (software for random allocation) such as Stata or R. For concealment in the research, we use concealment allocation. By using opaque, sealed, numbered sequentially envelopes, in this method, each random sequence created is recorded on a card, and the cards inside the letter envelopes are They are placed in order. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box. At the time of the registration of the participants, based on the order of entry of the eligible participants into the study, one of the envelopes will be opened and the allocation group of that participant will be revealed.
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 Jundi Shapur Ahvaz University of Medical Sciences
Street address
Ahvaz, Academic City, Vice-Chancellor of Research and Technology of Jundishapur University of Medical Sciences and Health Care Services, ground floor
City
ahvaz
Province
Khouzestan
Postal code
15794-61357
Approval date
2023-07-03, 1402/04/12
Ethics committee reference number
IR.AJUMS.REC.1402.198

Health conditions studied

1

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

Primary outcomes

1

Description
pain
Timepoint
Before the intervention - during the intervention - up to 30 seconds after the intervention
Method of measurement
Using the Infant Pain Profile (PIPP)

Secondary outcomes

1

Description
Behavioral responses
Timepoint
Before the intervention - during the intervention - up to 30 seconds after the intervention
Method of measurement
PIPP tool

Intervention groups

1

Description
Intervention group:Necessary intervention in infants is performed by an experienced nursing expert who is proficient in the hugo massage method in infants and has the relevant certificate. First, put on a clean gown and wash your hands for three minutes, and then warm your hands with a warmer to get the right temperature. Then he determines the place of massage. The massage place is between the two index fingers and the thumb, and its exact location is on the back of the hand, between the first and second metacarpal bones, in the middle of the second metacarpal bone in its axial direction. The best way to find Hugo's point is that Find the point where the thumb and index finger connect to each other at the bottom of the wrist and after finding this point, place your finger next to the bone of the index finger and about half an inch away from the beginning, and then after that Lean slightly towards your thumb. Another way to identify the exact location of Hugo's point is to stick two thumbs and index fingers together, so that a mass is formed between these two fingers. The middle of this mass is exactly the Hugo point. To perform this type of massage, first place your thumb or other finger exactly on that point and apply pressure to this point. Perform the massage in three times of one minute and with an interval of 30 seconds, 5 minutes before embedding. Oral-gastric tube and during its insertion is done by the nurse related to the baby.
Category
Rehabilitation

2

Description
Control group: The method of doing the work in the control group is that no massage will be done, and 2-3 minutes before inserting the gastric tube during the work and 30 seconds after, the pain score and behavioral responses will be measured using the PIPP tool. became .
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital, Ahvaz
Full name of responsible person
Ayoub Panahi
Street address
Ahvaz, 24 meter street, twenty four meter street, Ahvazian street
City
ahvaz
Province
Khouzestan
Postal code
5830038739
Phone
+98 61 3222 2114
Email
nadard21@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mehrnoosh Zakirkish
Street address
Ahvaz, Ostadan Quay, West Coast Boulevard, Golestan Boulevard
City
ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3373 8383
Email
mehr.zakerzadeh@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ayoub Panahi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Razm Avaran St., Shahid Yusuf Abroshan Alley
City
Ilam
Province
Ilam
Postal code
6931758473
Phone
+98 84 3333 2093
Fax
Email
panahi.a@ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ayoub Panahi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Razm Avaran St., Shahid Yusuf Abroshan Alley
City
Ilam
Province
Ilam
Postal code
6931758473
Phone
+98 84 3333 2093
Fax
Email
panahi.a@ajums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ayoub Panahi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Razm Avaran St., Shahid Yusuf Abroshan Alley
City
Ilam
Province
Ilam
Postal code
6931758473
Phone
+98 84 3333 2093
Fax
Email
panahi.a@ajums.ac.ir

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
Loading...