The Effect Of White Noise And Therapeutic Touch On Pain And Physiological Parameters In Premature Infants
Condition: Pain
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      Newborns hospitalized with some respiratory problems in the clinic are taken to noninvasive
      mechanical ventilation support and vascular access is required for some treatments to be
      applied to these newborns. The presence of nasal cannulas used for noninvasive mechanical
      ventilation support in newborns causes restlessness, agitation and stress in infants. The
      uneasiness and stress experienced by babies during vascular access also affects effective
      vascular access, causing other doses to be delayed or skipped due to treatment doses that are
      not completed on time. In addition, the pain experienced by babies indirectly affects nurses.
      It has been reported in many studies that it is effective in reducing the pain experienced by
      newborns with non-pharmacological methods. Simultaneous white noise will be played and
      therapeutic touch applied to help touch methods and white noise listening help reduce or
      control newborns' pain. Many studies have shown that touching to and listening white noise is
      effective in reducing pain. This study was planned as a randomized controlled experimental
      study to determine the effect of white noise-accompanied therapeutic touch application on
      pain level and physiological parameters and noninvasive mechanical ventilation support during
      peripheral intravenous catheterization in premature infants hospitalized for treatment.

      Hypothesis 0: The application of therapeutic touch with white noise during peripheral
      intravenous catheter intervention in premature infants has no effect on the level of pain.

      Hypothesis 1: White noise-accompanied therapeutic touch application reduces pain level during
      peripheral intravenous catheter intervention in premature infants.

      Hypothesis 2: The therapeutic touch application accompanied by white noise during peripheral
      intravenous catheter intervention in premature infants positively affects physiological
      parameters.
    

Detailed description: 
      Purpose of the research The study was planned as a randomized controlled experimental study
      to determine the effect of white noise and therapeutic touch on pain level and physiological
      parameters and noninvasive mechanical ventilation support during peripheral intravenous
      catheter intervention in hospitalized premature infants.

      As a data collection tool; "Baby Follow-up Form" was used in which some descriptive features
      of the baby and NIPS and physiological parameter measurements were evaluated.

      Application:

      The data of the study were collected using simple random sampling method. The newborns to be
      included in the study were divided into two groups as the intervention group and the control
      group. The data were determined according to the odd and even numbered days of the calendar
      between the research dates, and the babies born on the odd numbered days of the calendar were
      included in the white noise therapeutic touch group (intervention group), and the babies born
      on the even numbered days of the calendar were included in the control group. The
      environmental conditions in the two groups were regulated in the same way. The application
      was carried out with a research nurse performing therapeutic touch, an observer nurse and a
      practitioner nurse.

      Intervention Group (n=40) :

        -  Camera recording was started 5 minutes before intravenous catheter intervention, vital
           signs and pain were evaluated.

        -  Therapeutic touch application with white noise was started.

        -  Vital signs and pain were evaluated during intravenous catheterization.

        -  Vital signs and pain were evaluated when the intravenous catheter intervention was
           terminated and 5 minutes later, and the camera recording was stopped.

      Control Group (n=41):

        -  Camera recording was started 5 minutes before the intravenous catheter intervention,
           vital signs and pain were evaluated.

        -  No application was made other than intravascular catheter intervention.

        -  Vital signs and pain were evaluated during intravenous catheterization.

        -  Vital signs and pain were evaluated when the intravenous catheter intervention was
           terminated and 5 minutes later, and the camera recording was stopped.

      Universe and Research Example Newborns treated at Zeynep Kamil Gynecology and Pediatrics
      Training and Research Hospital Neonatal Intensive Care Service between June 2021 and January
      2022 constitute the population of the research. The sample of the study consisted of 85
      newborns meeting the sampling criteria of the study in the Neonatal Intensive Care Service of
      Zeynep Kamil Gynecology and Pediatrics Training and Research Hospital.

      Sampling selection criteria of the infant;

        -  32-36. to be born in gestational weeks,

        -  The need for noninvasive mechanical ventilation,

        -  Absence of congenital anomalies,

        -  Appropriate cognitive level and motor development of the newborn,

        -  Does not prevent the opening of the vascular access,

        -  Not using narcotic, sedative opioid and anticonvulsant drugs,

        -  No pharmacological intervention for the baby's pain during the procedure,

        -  Parents sign the informed consent form. Dependent Variables: The newborn's heart rate,
           respiratory rate, oxygen saturation, body temperature, blood pressure, pain score are
           the dependent variables.

      Independent Variables: The sex of the newborn, gestational age, mode of delivery, weight,
      height, head circumference, type of feeding, type of noninvasive mechanical ventilation
      support constitute the independent variables.

      Sample size was determined by power analysis. In the study, the power of the sample was
      calculated with the G*Power 3.1 program. The amount of type I error was 0.05 and the power of
      the test =0.80 (α=0.05, 1-β=0.80, effect size:0.6), while the minimum sample size (36
      newborns in each group) was 72. newborns Considering the losses that may arise from the
      sample for any reason during the study period, it is planned to take 10% more of the power
      analysis result. In the study, 40 newborns were included in the intervention group
      (therapeutic touch with white noise) and 41 newborns in the control group.

      Data Collection Written permission from the ethics committee of Zeynep Kamil Gynecology and
      Pediatrics Training and Research Hospital (Annex-3) and research permission from the Istanbul
      Governorship Provincial Health Directorate (Annex-4) for the collection of pre-research data.
      After explanations were given to the families of the newborns who agreed to participate in
      the study, and to the families of the newborns who met the sample selection criteria for the
      purpose of the study, verbal and written informed consent was obtained from the families of
      the newborns who agreed to participate in the study (Annex-1). During the research, personal
      information will be kept confidential and care will be taken for their privacy. The data of
      the study were collected between June 2020 and January 2021. The application time of each
      data and filling the data collection forms took an average of 20-25 minutes.

      Evaluation of Data The data of the study were analyzed with appropriate statistical methods
      using the SPSS (Statistical Package for the Social Science) 22.0 package program. In the
      evaluation of the data, percentage, number, mean and standard deviation were used as
      descriptive statistical methods, and frequency and percentage distributions of the data were
      given. The relationship between the variables measured at the categorical level was evaluated
      with the Pearson chi-square test. Whether the research variables showed normal distribution
      or not was examined by paired test and independent group t test. The significance level was
      0.05; It was stated that there was a significant difference in cases with p<0.05, and there
      was no significant difference in cases with p>0.05.
    

Intervention name(s): Therapeutic touch group accompanied by white noise
Intervention type(s): Behavioral
Intervention description(s): During the intravenous catheter intervention, approximately 15-20 minutes of white noise was applied with therapeutic touch.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled two groups (control groups and intervention group)
Masking: None (Open Label)
Primary purpose: Prevention