Effect of Maternal Kisses on Pain, Anxiety, and Fear
Condition: Chin Injury
Study type: Interventional

Summary: 
      Although the effectiveness of maternal kisses for minor injuries in childhood is
      traditionally accepted, its effect on invasive procedures has not yet been proven. The aim of
      this study is to determine the effect of maternal kisses applied to children aged 5-7 years
      on pain, anxiety, and fear levels during invasive procedures. The population of the
      pretest-posttest single-blind randomized controlled experimental study consisted of 124
      children aged 5-7 years who applied to the pediatric gastroenterology clinic , and the sample
      consisted of 84 children. A stratified block randomization method was used in the study. The
      maternal kisses were applied to the experimental group during the invasive procedure, and the
      standard invasive procedure was applied to the control group. The effect of maternal kisses'
      on reducing pain, anxiety, and fear in children during invasive procedures is being
      investigated.
    

Detailed description: 
      Method

      Type of study

      The design of this study was a randomised controlled experimental study with a single blind
      pre-test post-test control group. The study was conducted according to CONSORT guidelines.

      Hypotheses H01: Mother's kiss during invasive intervention has no effect on pain.

      H11: Mother's kiss during invasive intervention has an effect on pain.

      H02: Mother's kiss during invasive intervention has no effect on anxiety.

      H12: Mother's kiss during invasive intervention has an effect on anxiety.

      H03: Mother's kiss during invasive intervention has no effect on fear.

      H13: Mother's kiss during invasive intervention has an effect on fear.

      Population and Sample

      The population of the study consisted of 124 children aged 5-7 years who applied to a private
      pediatric gastroenterology clinic for diagnosis and treatment between 11 January 2023 and 5
      May 2023, and the sample consisted of 84 children. The minimum sample size was calculated
      with GPower 3.1 Statistical Software. Since the effect size could not be determined in a
      similar study, a pilot study was conducted with a total of 10 people, five people per group
      in the intervention and control groups. Pilot applications were not included in the study
      afterwards. In line with the data obtained from the pilot study, the effect size calculated
      using the mean and standard deviation of the fear level scores of the children in the
      intervention and control groups at the 5th minute was d:0.73. Accordingly, for an effect size
      of d:0.73, alpha:0.05 and 1-alpha:0.95, the number of people to be sampled within each group
      was determined as 42 and 84 in total. The study was completed with a total of 84
      participants. As a result of the PostHoc power analysis performed after the data were
      collected, the power of the test was determined as 99.9% with 95% confidence (1-alpha),
      d=0.97 effect size and n=84 participants. The effect size used in the PostHoc analysis was
      calculated by using the mean and standard deviation of the fear level scores of the children
      in the intervention and control groups at the 5th minute.

      Application

      After obtaining the necessary permissions, the data were collected by the researcher through
      face-to-face interviews. The eligibility of the children and their parents who were admitted
      to the pediatric gastroenterology clinic and decided to undergo invasive intervention after
      examination were evaluated. Then, the verbal consent of the children who volunteered to
      participate in the study and met the inclusion criteria and the written consent of the
      mothers were obtained. Stratified randomisation method was used to assign the children to the
      groups. Then, according to the type of intervention to be applied, the child and the parent
      were included in the relevant section. Blood collection and observation rooms, where invasive
      interventions are performed, are separated by a screen for one person and designed to protect
      privacy. All data collection tools except the pain scale were administered to the children in
      the intervention and control groups as pretest. Mother's kiss was applied to the intervention
      group. The control group underwent invasive intervention with the standard method. Before the
      application, it was checked whether the parents had oral ulcers. The parents of the children
      in the intervention group were informed about the process before the application. Immediately
      after the invasive procedure was finished, the parent was asked to approach his/her child and
      say, "Let me kiss you and make it better" and to kiss his/her child from a point not close to
      where the invasive procedure was performed. Kisses were delivered by mother, free of oral
      ulcers, with a standard 5-second pressing of both lips on the affected body part followed by
      an exaggerated puckering sound. Pain, fear and anxiety scales were re-administered to both
      groups at the 1st and 5th minutes after the application. Invasive interventions were
      performed by the researchers who had been working as nurses for 4 years and by the medical
      doctor. The same procedures were repeated for each child who met the inclusion criteria. The
      parents of the children in the control group remained in the same environment with their
      child during the invasive intervention. After the application process was completed, the
      children in the control group were also provided with the mother's kiss application.

      Data Evaluation

      The data of the study were evaluated using Statistical Package for Social Sciences (SPSS)
      (23.0) programme in computer environment. The conformity of the data to normal distribution
      was evaluated by Shapiro-Wilk tests. Number, percentage, mean, standard deviation were used
      in data analysis, and chi-square test was used to determine homogeneity in categorical
      variables. Since the data were normally distributed, repeated measures analysis of variance
      with Bonferroni correction was used for intra-group comparisons and independent samples t
      test was used for inter-group comparisons. The significance level was determined as p<0.05.

      Ethical Aspects of the Study

      The study was conducted in accordance with the principles of the Declaration of Helsinki.
      Ethics committee permission was obtained from Bandırma Onyedi Eylül University Health
      Sciences Non-Interventional Research Ethics Committee (Date: 18.10.2022, Number:2022-9).
      Then, permission was obtained from the clinic where the study would be conducted. Before the
      data were collected, the children and their parents were informed about the purpose and scope
      of the study and their verbal consent was obtained by asking whether they agreed to
      participate in the study, and the written consent of the parents who agreed to participate in
      the study was obtained through the Informed Voluntary Consent Form. Patient rights and
      privacy as well as ethical rules were observed throughout the whole process.
    

Intervention name(s): Maternal kisses
Intervention type(s): Other
Intervention description(s): The parents of the children in the experimental group were informed about the process before the application. The parents were asked to approach their child immediately after the invasive procedure was over, call out "Let me kiss it better" and kiss the child from a point not close to the place where the invasive procedure was applied. Kisses were delivered by the mother, free of oral ulcers, with a standard 5-second pressing of both lips on the affected body part followed by an exaggerated puckering sound. Pain, fear, and anxiety scales were administered to the intervention group at the 1st and 5th minutes after the application. Invasive interventions have been applied by researchers who have been working as nurses in the emergency room for 4 years.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The design of this study is a randomized controlled experimental study with a single-blind pretest-posttest control group.
Masking: Single (Care Provider)
Primary purpose: Other
Keywords: Evidence-Based Nursing; Pain Management; Fear; Anxiety