Effect of Maternal Kisses on Pain, Anxiety, and Fear (NCT05892601) | Clinical Trial Compass
CompletedNot Applicable
Effect of Maternal Kisses on Pain, Anxiety, and Fear
Turkey (Türkiye)84 participantsStarted 2023-01-11
Plain-language 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.
Who can participate
Age range
5 Years – 7 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria (Mother)
* Being over 18 years of age
* Speaking Turkish
* Having two lips with which to apply the kiss
* Written informed consent
Exclusion Criteria (Mother)
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial studied whether a mother's kiss could reduce pain in children with chin injuries — if my child has a minor chin injury, is this something their pediatrician thinks could actually help manage their pain in a real clinical setting?
2The trial used the Wong-Baker Faces Pain Rating Scale to measure pain — can you explain what that scale is and whether the results showed a meaningful difference in how much pain children reported with or without a maternal kiss?
3Since this trial is now completed, has the data been published anywhere, and would you be able to share what the findings showed about anxiety and fear in addition to pain?
4This study was listed as Phase NA, which often applies to behavioral or non-drug interventions — does that mean there are fewer safety concerns to weigh compared to a medication trial, and is this approach already considered safe to try at home?
5Are there situations where a chin injury in a child would be serious enough that comfort measures like this wouldn't be sufficient on their own, and how would I know when my child needs more than reassurance and a kiss?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.