Let me Kiss it Better! Maternal Kisses Are Effective in Alleviating Pain, Anxiety, and Fear in Children During Invasive Procedures: A Randomized Controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 84
- Locations
- 2
- Primary Endpoint
- Wong-Baker Faces Pain Rating Scale
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Care Provider)
Masking Description
Stratified block randomisation method was used to assign the participants to the intervention and control groups. To prevent bias, randomisation was performed by an unbiased nurse who was not involved in the study. In order to control the imbalances that may arise between the intervention and control groups, stratification (2X2) was made according to gender (girls, boys) and age (5,6,7) and an equal number of children were assigned to each group (blocking). Assignments were made according to a list generated by an online randomisation tool. All participants completed the study process and there was no case loss. The parents of the children who participated in the study were unaware of which group their children were in. Since the applications were carried out by the researcher, researcher blinding could not be performed. Therefore, the study is single blind.
Eligibility Criteria
- Ages
- 5 Years to 7 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Being over 18 years of age
- •Speaking Turkish
- •Having two lips with which to apply the kiss
- •Written informed consent
Exclusion Criteria
- •Having oral ulcers
- •Accused or convicted of child abuse or neglect
- •Inclusion Criteria (Child)
- •Being in the age range of 5-7 years
- •Admission to pediatric gastroenterology clinic for diagnosis and treatment
- •Stable general condition
- •Invasive intervention performed in a single attempt
- •Not having visual and hearing problems
- •Not having any pain (due to illness, side effects of medication, distension)
- •Not having a chronic disease (kidney, diabetes, etc.) that requires frequent invasive intervention
- •Being at the level of mental development to answer the questions asked
- •Speaking and understanding Turkish easily
- •Volunteering to participate in the study
- •Exclusion Criteria (Child)
- •Having a history of epilepsy, vertigo and neurological diseases
- •History of syncope during blood collection
- •Having a disease that causes chronic pain
- •Complications during invasive intervention (allergy, syncope, etc.)
- •Being in life-threatening condition and taken to the resuscitation room
- •Deciding that the child is a forensic case after the examination
- •In the intervention group, the parent makes an intervention other than kissing the child within 5 minutes
- •In the control group, the parent makes any intervention to his/her child within 5 minutes
Outcomes
Primary Outcomes
Wong-Baker Faces Pain Rating Scale
Time Frame: 5th minute
Wong-Baker Faces Pain Rating Scale: There are 6 different facial expressions scored between 0 and 5 on the scale. A smiling face means no pain, a crying face means unbearable pain. Explain the meaning of facial expressions to the child. Then, they are asked to show the face that best expresses the level of pain when asked. The number on the facial expression specified by the child is recorded. As the score obtained from the scale increases, pain tolerance decreases.
Secondary Outcomes
- Child Fear Scale(5th minute)
- Child Anxiety Scale-State(5th minute)
Investigators
Emre Ciydem
Assistant Professor
Bandırma Onyedi Eylül University