Clinical trial NCT06983093: Effects of Rain Stick and Musical Egg on Pain, Fear and Anxiety
Official title: Effects of Rain Stick and Musical Egg on Pain, Fear and Anxiety During Blood Collection in Children Aged 4-6: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Procedural Pain
Procedural Anxiety
Fear Needles
Lead sponsor: Hakkari Universitesi
Sponsor class: OTHER
First posted: 2025-05-21
Enrollment: 120
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention Group-Rainstick Group: The rainstick method will be used as a non-pharmacological application for the children in this group. The rainstick will be given to the children and during the blood collection process, the researcher or parent will turn it up and down to watch the sounds and movements and if they wish, they will be allowed to take the toy with their free hand.

Intervention Group-Musical Egg Group: The musical egg method will be used as a non-pharmacological application for the children in this group. The musical egg will be given to the children and during the blood collection process, the researcher or parent will turn it up and down to watch the sounds and movements and if they wish, they will be allowed to take the toy with their free hand.

Control Group: The child will be seated in the intervention chair. No pharmacological or non-pharmacological method will be applied to the children in this group other than the routine blood collection process.
Primary purpose: PREVENTION

Brief summary: This research will be conducted in a pre-test-post-test parallel group randomized controlled experimental study model to determine the effects of rain stick and musical egg applied during blood collection on pain, fear and anxiety in children aged 4-6.

Research Hypotheses H1: The mean pain scores of the children in the rain stick group are lower than the mean scores of the children in the control group.

H2: The mean fear scores of the children in the rain stick group are lower than the mean scores of the children in the control group.

H3: The mean anxiety scores of the children in the rain stick group are lower than the mean scores of the children in the control group.

H4: The mean pain scores of the children in the musical egg group are lower than the mean scores of the children in the control group.

H5: The mean fear scores of the children in the musical egg group are lower than the mean scores of the children in the control group.

H6: The mean anxiety scores of the children in the musical egg group are lower than the mean scores of the children in the control group.

Detailed description: Blood collection is one of the most frequently performed invasive procedures in the health sector for years, and it is a stressful situation for all age groups. It causes intense pain, fear and anxiety, especially for children. Although it is known as the preschool period, especially between the ages of four and under, children believe that the needle puncture procedure will disrupt their body integrity and cause disability, and they think that they are being punished for not listening to their parents. These thoughts can also cause the child to experience pain, fear and anxiety. Negative experiences and pain resulting from invasive procedures can lead to negative situations such as needle phobia and avoidance of healthcare personnel. For all these reasons, invasive procedures, which are an important source of pain, fear and anxiety in children, need to be managed effectively. During painful and stressful medical procedures applied to the child, using a timely and effective method to control pain, fear and anxiety will increase tolerance to pain, fear and anxiety in later applications. Pain, fear and anxiety management requires the work of a multidisciplinary team (nurse, physician, other healthcare personnel). In eliminating children's fear of medical procedures, all healthcare professionals, especially nurses, have important responsibilities as the first people to greet children in the hospital and spend the most time with them. Diagnosing, evaluating, and observing the child's pain, fear, and anxiety, preventing complications by applying non-pharmacological nursing interventions, and administering analgesics upon doctor's request are among the roles and responsibilities of nurses. Nurses involved in the treatment of pain, fear, and anxiety carry out a complex care process by applying medical and complementary treatments together. In particular, non-pharmacological complementary treatments, which are independent nursing roles, are effectively applied in eliminating pain, fear, and anxiety symptoms. Various studies emphasize the importance of nursing interventions in preventing and reducing pain, fear and anxiety in children during invasive procedures and controlling the negativities that will be reflected in the treatment process. One of the most frequently preferred non-pharmacological methods for controlling pain, fear, and anxiety that occur during invasive procedures in children is distraction. This method is a nursing intervention that allows the patient's attention to be better controlled by focusing the pain and anxiety elsewhere. With this method, the child protects himself from feeling pain. Distraction methods can be helpful in reducing children's perception of pain, increasing pain tolerance, and providing relaxation, especially during invasive procedures. There are many different methods used to distract attention. Some of these are; listening to music, playing games, using distraction cards, watching cartoons, blowing balloons, creating balloons by blowing foam, watching kaleidoscopes and using virtual reality glasses. In order for distraction methods to be effective, they must be appropriate for the child's age. In the preschool period, audio and visual toys can be effective in distracting children's attention. Play is a tool that helps the child's ability to cope with and adapt to problems by transferring their experiences and fears related to traumatic events that disturb their self to play and toys, and thus reducing pain, fear and anxiety. It is reported that during play, the child's handling and familiarization with the tools used in treatment will reduce pain, fear and anxiety by perceiving them as less threatening. In a study, it was observed that a lighted rotating musical toy used as one of the techniques to divert attention during the blood collection process of preschool children (4-6 age group) reduced the children's pain and fear levels. When the studies in the literature were examined, it was seen that there were limited studies examining the effect of a lighted, moving, musical toy on pain and anxiety in children between the ages of 4-6 during the blood collection procedure in that age group. In this case, it is difficult for nurses to decide on the practices they will use based on the limited research results regarding the use of musical toys in children during blood collection procedures. In the literature review, no studies were found investigating the effects of musical toys such as rain sticks and musical eggs on pain, fear, and anxiety in children during blood collection procedures. Therefore, it is thought that this randomized controlled and experimental study will contribute to the literature and nurses in the field, and will be useful in terms of creating an evidence-based resource for nursing science.

Eligibility criteria: Inclusion Criteria:

* The child must be between 4-6 years old
* The child must not have acute pain
* The child must not have mental or auditory disabilities
* The child must not have confusion
* The child and parent must agree to participate in the study

Exclusion Criteria:

* The child must be under 4 years old and over 6 years old
* The child's body temperature must be 38°C or above
* The child must have used an analgesic medication in the last 24 hours before the application

Primary outcomes:
measure: Pain During Blood Collection Procedure in Children
timeFrame: "1 year"
measure: Fear During Blood Collection Procedure in Children
timeFrame: "1 year"
measure: Anxiety During Blood Collection Procedure in Children
timeFrame: "1 year"
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: