Development and Efficiency of Atraumatic Orogastric Tube Insertion Protocol With Combination of Wrapping, Fetal Position, Breastmilk, and Sucrose
Condition: Premature; Orogastric Tube; Oral Sucrose
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      This study aimed to reduce the pain and increase comfort during the orogastric tube insertion
      (OGT) procedure, which is routinely applied to feed these babies at 32-34 weeks of age, in
      preterm newborns with a sucking reflex.In addition, this study also aimed to develop an
      atraumatic OGT attachment protocol by combining wrapping, fetal position, breast milk and
      oral sucrose combined therapy.

      It was planned as a randomized double-blind and controlled experimental study to evaluate the
      efficacy of using In addition, this study also planned to develop the atraumatic OGT
      insertion procedure through combined therapy of wrapping, fetal position, breast milk, and
      oral sucrose. The population of the research consists of preterm babies who are treated in
      the Neonatal Intensive Care Unit of Selcuk University Hospital. Babies to be sampled are
      preterm babies who are between 32 and 34 weeks of gestation.

      Preterm newborns will be randomly divided into five groups;

        -  Group 1: Control

        -  Group 2: Wrapping + breast milk (2 ml)

        -  Group 3: Wrapping + oral sucrose (0.2 ml/kg 20% sucrose)

        -  Group 4: Fetal position + breast milk (2 ml)

        -  Group 5: Fetal position + oral sucrose (0.2 ml/kg 20% sucrose) In the NICU, OGT
           insertion will be performed by the clinical nurse as part of the treatment for preterm
           newborns, which the clinic physician deems necessary. The clinical nurse and clinician
           will be responsible for OGT insertion in preterm newborns. In this study, only wrapping,
           fetal positioning, oral breast milk and sucrose delivery methods will be applied to
           preterm newborns by the researcher. In this context, the responsibility of the
           researcher in the study will be to apply non-pharmacological methods to preterm newborns
           only before OGT insertion and to evaluate the pain symptoms in preterm newborns during
           and after OGT insertion.

      The obtained data will be evaluated in SPSS-21 package program in computer environment.
      Normality tests, chi-square, t test, Anova, and advanced analysis will be used when necessary
      in the analysis of the data. The relationship between the mean score of the scale and other
      variables will be evaluated by correlation regression analysis. Significance will be accepted
      as p<0.05.
    

Detailed description: 
      Ethical and institutional permissions were obtained before starting to collect the data.
      Written consent will be obtained from all parents via a voluntary consent form. Preterm
      newborns will be randomly selected into 5 groups.

        -  Group 1 (Control Group); Wrapping+breastmilk, wrapping+sucrose, fetal position+sucrose
           and fetal position+breastmilk methods were not applied to preterms in the routine care
           group. However, in order to be an ethical practice and to provide ethical standard care
           intervention, verbal relaxation and soft touch applications were applied by the
           researcher in the procedure.

        -  Group 2 (Wrapping + Breastmilk Group); Preterm newborns will be wrapped by the
           researcher 10 minutes before OGT insertion. Then, 2 ml of breast milk will be given by
           the researcher with a sterile syringe 2 minutes before the OGT insertion to the same
           newborn. Breast milk will be given slowly into the mouth of the preterm newborn, on the
           upper part of the tongue, through an injector. Preterm newborns will be recorded with a
           video camera for 10 minutes before the procedure and for 5 minutes during and after the
           procedure. Then, using video recordings, the pain and comfort of newborns will be
           evaluated at the 1st minute before the procedure, at the 1st minute and 2nd minute (4
           measurements) during and after the procedure.

        -  Group 3 (Wrapping + Oral Sucrose Group); Preterm newborns will be wrapped by the
           researcher 10 minutes before OGT insertion. Then, 2 ml of 20% oral sucrose will be given
           to the same newborn by the researcher with a sterile syringe 2 minutes before OGT
           insertion. Oral sucrose will be slowly introduced into the mouth of the preterm newborn
           on the upper part of the tongue through an injector. Preterm newborns will be recorded
           with a video camera for 10 minutes before the procedure and for 5 minutes during and
           after the procedure. Then, using video recordings, the pain and comfort of newborns will
           be evaluated at 1 minute before the procedure, during and after the procedure at 1
           minute and 2 minutes (4 measurements).

        -  Group 4 (Fetal Position + Breastmilk Group); The fetal position will be given to the
           preterm newborn immediately after 2 ml of breast milk is given by the researcher 3
           minutes before OGT insertion. Breast milk will be given slowly into the mouth of the
           preterm newborn, on the upper part of the tongue, through an injector. The preterm
           newborn will remain in the fetal position for 5 minutes during and after the procedure.
           Newborns will be recorded with a video camera before, during and after the procedure.
           Then, using video recordings, the pain and comfort of newborns will be evaluated at the
           1st minute before the procedure, at the 1st minute and 2nd minute (4 measurements)
           during and after the procedure.

        -  Group 5 (Fetal Position + Oral Sucrose Group); The fetal position will be given to the
           preterm newborn immediately after 2 ml of oral sucrose is given by the researcher 3
           minutes before OGT insertion. Oral sucrose will be slowly injected into the mouth of the
           preterm newborn on the upper part of the tongue by means of an injector. At the end of
           the 3rd minute, the clinic nurse will insert the OGT as part of the treatment. The
           preterm newborn will remain in the fetal position for 5 minutes during and after the
           procedure.

      Newborns will be recorded with a video camera before, during and after the procedure. Then,
      using video recordings, the pain and comfort of newborns will be evaluated at the 1st minute
      before the procedure, at the 1st minute and 2nd minute (4 measurements) during and after the
      procedure.

      Hypotheses (H1) There is a significant difference between the methods applied in the OGT
      insertion procedure (wrapping+breastmilk, wrapping+sucrose, fetal position+sucrose and fetal
      position+breastmilk) in terms of heart rate in preterms.

      There is a significant difference between the methods applied in the (H2) OGT insertion
      procedure in terms of oxygen saturation of preterms.

      (H3) There is a significant difference between the methods applied in the OGT insertion
      procedure in terms of the estimated pain score of preterms.

      (H4) There is a significant difference between the methods applied in the OGT insertion
      procedure in terms of the estimated distress score of preterms.

      (H5) There is a significant difference between the methods applied in the OGT insertion
      procedure in terms of the comfort level of preterms.

      (H6) There is a significant difference between the methods applied in the OGT insertion
      procedure in terms of the mean of preterm pain in preterms.
    

Intervention name(s): Wrapping + Breastmilk Group
Intervention type(s): Other
Intervention description(s): Interventions applied during orogastric tube insertion
Other intervention name(s): Wrapping + Oral Sucrose Group; Fetal Position + Breastmilk Group; Fetal Position + Oral Sucrose Group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Premature; orogastric tube; oral sucrose; Wrapping