Effect of Acupressure on Interventional Pain in Infants
Condition: Procedural Pain; Child, Only
MeSH terms: Pain, Procedural
Study type: Interventional

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.
    

Intervention name(s): Acupressure; Placebo Acupressure
Intervention type(s): Procedure; Procedure
Intervention description(s): This study will be conducted in a randomized placebo-controlled research design to investigate the effect of acupressure, to be applied to the Gall Bladder (GB) 31 "Fengshi" acupuncture point before the vaccinations, on interventional pain in infants (0-1 years) caused by the vaccine.; Placebo Acupressure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Infant; Procedural Pain; Acupressure