Clinical trial NCT05166551: Effect of Acupressure on Interventional Pain in Infants
Official title: The Effect of Acupressure on Interventional Pain in Infancy Period Before Immunization: A Randomized Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Procedural Pain
Child, Only
Keywords: Infant
Procedural Pain
Acupressure
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2021-12-22
Enrollment: 105
Sex: ALL
Minimum age (years): 5
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will be conducted to investigate the effect of acupressure, to be applied to the GallBladder (GB) 31 "Fengshi" acupuncture point before the vaccinations, on interventional pain caused by the vaccinations in infants. Considering the literature, it can be seen that acupressure is used in many fields and it's among the non-pharmacological methods that have been used by nurses in recent years.However, no study has been found to be conducted on the effect of acupressure, applied before the vaccine, on interventional pain caused by the vaccinations in infants. Therefore, this study aims to investigate the effect of acupressure applied before the vaccination on interventional pain in infants.

Detailed description: Aim: This study will be conducted in a randomized placebo-controlled research design to investigate the effect of acupressure, to be applied to the GB31 acupuncture point before the vaccinations, on interventional pain in infants (0-1 years) caused by the vaccine.

Introduction: As a non-pharmacological method originating from traditional Chinese medicine with a 5000-year history, acupressure is used in different parts of the world as a method of treatment (Gach, 1990, Pour, Ameri, Kazemi, \& Jahani, 2017). There are some points in the body that have great potential for energy transmission and are known as acupuncture points. In acupressure therapy, the body's regulatory processes are stimulated by applying pressure using fingers to acupuncture points located on the surface of the skin. The same points are used in acupuncture and acupressure. While acupuncture is performed using a needle, acupressure is performed by hands to make gentle but firm pressure (Ahmedov, 2015, Gach, 1990, Özşar, 2006). Acupressure is a more acceptable form of therapy for pediatric age groups since it is a non-invasive procedure (Abbasoğlu et al., 2015). In addition, its low cost, lack of side-effects, and its nature not requiring specific abilities for application are also among the advantageous aspects of this therapy (Wang, Escalera, Lin, Maranets, \& Kain, 2008).

This study will be conducted to investigate the effect of acupressure, to be applied to the GB31 acupuncture point before the vaccinations, on interventional pain caused by the vaccinations in infants. The GB31 acupuncture point is located on the lateral midline of the thigh, 7 cun \[(depends on patient's height), in adults 1 cun = approximately 3.3 cm\] above the transverse popliteal fold, the point where the tip of the middle finger comes into contact when the patient is standing and lying flat on his/her back and putting his/her hands on the sides.

Considering the literature, it can be seen that acupressure is used in many fields and it's among the non-pharmacological methods that have been used by nurses in recent years. In this context, according to some nursing studies of acupressure on children, acupressure was found to be effective in reducing nausea and vomiting in children with cancer (Jones, Isom, Kemper, \& McLean, 2008, Yeh et al., 2012), relieving the side-effects of chemotherapy and reducing fatigue (Farideh Bastani, Khosravi, Borimnejad, \& Arbabi, 2015), improving quality of sleep (Carotenuto, Gallai, Parisi, Roccella, \& Esposito, 2013), relieving the symptoms of asthma (Liu \& Chien, 2015), reducing physical stress (Das, Nayak, \& Margaret, 2011), alleviating postoperative symptoms (Norheim, Liodden, \& Howley, 2010), and alleviating interventional pain (Koç Özkan, Şimşek Küçükkelepçe, \& Aydin Özkan, 2019, Oğul \& Yilmaz Kurt, 2021, Pour et al., 2017). However, no study has been found to be conducted on the effect of acupressure, applied before the vaccine, on interventional pain caused by the vaccinations in infants. Therefore, this study aims to investigate the effect of acupressure applied before the vaccination on interventional pain in infants.

Study Population and Sampling: The study population consists of the infants (regardless of gender) followed for vaccination by the studied university hospital, under the routine immunization program of the Ministry of Health, and the study sample will consist of infants who meet the research inclusion criteria. A power analysis was performed in order to determine the sample size. In the study, the power analysis was performed using the Gpower v.3.1.9.4 program. The study conducted by Unesi, Sajed, \& Sharifzadeh (2019) was used to calculate the sample size (Unesi, Sajed, \& Sharifzadeh, 2019). In the study, the minimum number of samples required was found to be 35 in each group (Type I Error = .05, The Power of the Test= .90), with the expectation that there should be statistical significance between the FLACC pain scale points of the infants in the intervention and control groups during the procedure. The study was planned to be completed with a total of 105 infants, including 35 in the experimental group, 35 in the placebo group, and 35 in the control group.

Data Collection Method: The data will be collected by the researcher in the unit where the study is planned to be carried out.

The following will be used in the collection of data:

* Data Collection Form, prepared by the researcher to determine the demographic characteristics of the infant, the researcher was conducted in accordance with the literature (Abbasoglu et al., 2015, Ahmedov, 2015, Tugcu et al., 2015). Some of the informations for this form (such as week of gestation, gender and anthropometric measurements in birth) will be taken from the child's personal records.
* Face, Legs, Activity, Cry, Consolability (FLACC) scale to determine the pain score of the infant during the administration of the vaccine (after the vaccination),
* Pulse Oximeter Device for detecting oxygen saturation (SPO2) and heart rate (HR) before, during and after vaccination of infants,
* Weighing Instrument to determine the current weight of infants,
* Height Measuring Tape to determine the current height of infants,
* Head Circumference Measurement Tape to determine the current head circumference of infants,
* Stopwatch of a smartphone for determining the crying duration of infants

Experimental Group Data Collection: After measuring the height, weight, and head circumference of the infants in this group, which are fed before the procedure and allowed to calm down on their mother's lap, acupressure will be applied by the researcher on the GB31 acupuncture point, on the leg to be vaccinated, for 1 minute in accordance with the acupressure technique. Detailed descriptions of the acupressure application technique and how much pressure will be applied to the selected points will not be included in the study. The considerations before during and after acupressure application are as follows:

* Before the acupressure application, hands will be washed to warm them up to body temperature.
* In accordance with the literature, acupressure will be applied using the thumb to the GB31 acupuncture point (on the lateral midline of the thigh, 7 cun above the transverse popliteal fold, the point where the tip of the middle finger comes into contact when the patient is standing and lying flat on his back and putting his/her hands on the sides) for 1 minute before the vaccine is administered to the infants in the experimental group.
* Pain scoring will be performed using the FLACC scale by the parents, the observing nurse, and the researcher after the vaccination procedure. In addition, the HR and SPO2 level of the infants before, during and after the procedure will be evaluated and recorded by the researcher. Pulse oximeter will be used in the evaluation process.The crying time of infants will also be recorded. Stopwatch will be used in the evaluation process.
* In terms of the reliability of the research results, the vaccine administration will be carried out by the same nurse working in the vaccine unit.

Placebo Group Data Collection: After measuring the height, weight, and head circumference of the infants in this group, which are fed before the procedure and allowed to calm down on their mother's lap, pressure will be applied by the researcher on a placebo (sham) point at least 2 cun above the GB31 acupuncture point, on the leg to be vaccinated, for 1 minute.

The following are the considerations to be taken into account before, during, and after the pressure application:

* Before the acupressure application, hands will be washed to warm them up to body temperature.
* For the infants in the placebo group, pressure will be applied using the thumb for 1 minute to a point (sham point) that does not coincide with any acupuncture point at least 2 cun above the acupuncture point before the vaccine is administered.

After the infants in the placebo group are allowed to calm down on the mother's lap for 5 minutes, pain scoring will be performed using the FLACC scale by the parents, the observing nurse, and the researcher, after the vaccination procedure. In addition, the HR and SPO2 level of the infants before during and after the procedure will be evaluated and recorded by the researcher.Pulse oximeter will be used in the evaluation process.The crying time of infants will also be recorded.Stopwatch will be used in the evaluation process. In terms of the reliability of the research results, the vaccine administration will be carried out by the same nurse working in the vaccine unit.

Control Group Data Collection: The infants in this group will be fed before the procedure, their height, weight, and head circumference will be measured and they will be allowed to calm down on their mother's lap. Without any intervention, the infants in this group will be allowed to calm down on the mother's lap for 5 minutes, and pain scoring will be performed using the FLACC scale by the parents, the observing nurse, and the researcher, after the vaccination procedure. In addition, the HR and SPO2 level of the infants before, during and after the procedure will be evaluated and recorded by the researcher.Pulse oximeter will be used in the evaluation process.The crying time of infants will also be recorded.Stopwatch will be used in the evaluation process. In terms of the reliability of the research results, the vaccine administration will be carried out by the same nurse working in the vaccine unit.

Eligibility criteria: Inclusion Criterias:

* Being healthy
* To be older than 4 weeks
* To be less than 1 year old
* Parents' consent to participate in the study
* To be born between 38-42 gestational weeks
* To take part in the routine vaccination program of the Ministry of Health

Exclusion Criterias:

* Being a sick infant
* To be over 1 year old
* Have taken analgesics in the last 4 hours
* To be born lower than 37 gestational weeks
* Parents' don't consent to participate in the study

Primary outcomes:
measure: Pain severity
timeFrame: Starting with the vaccination and up to 1 minute after the procedure
Secondary outcomes:
measure: Heart rate (HR)
timeFrame: Before (1 minute), during and after (1 minute) the procedure
measure: Peripheral oxygen saturation level (SPO2)
timeFrame: Before (1 minute), during and after (1 minute) the procedure
measure: Criying time
timeFrame: After the procedure (1 minute)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpaşa
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Duygu GÖZEN, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
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