Procedural PainNCT06983093
Effects of Rain Stick and Musical Egg on Pain, Fear and Anxiety
A study testing Rain Stick and Musical Egg in people with Procedural Pain and Procedural Anxiety, run by Hakkari Universitesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Procedural Pain, Procedural Anxiety, Fear Needles
- What is being tested?
- Rain Stick and Musical Egg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Oct 2025to 31 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr. Ali Kemal Belviranlı Obstetrics and Gynecology and Children's Hospital
Konya
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Procedural Pain, Procedural Anxiety, Fear Needles
- Being tested
- Rain Stick, Musical Egg
- Medical subject headings
- Pain, Procedural, Iatrophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rain StickOther
The rain stick to be used in the study is a toy made of wood, ranging in length from 20 to 120 cm. It is also a very entertaining musical instrument that imitates the sound of real rain. It is suitable for use by children aged 4 to 6. It has spiral shapes and colorful beads inside. When the rain stick is turned up and down, it produces a perfect rain sound that drizzles and patters. It is also known as a rain sound stick. The visual and auditory nature of the rain stick can distract the child during the blood collection process.
Musical EggOther
The musical egg to be used in the study is a toy made of wood, approximately 6.5-7 cm in size. These wooden shaker eggs are a fun and interesting musical instrument. It is suitable for use by children aged 4-6. It is filled with iron sand and when shaken, it makes a clear sound and adds a unique rhythm to the music. This egg imitates the sound of maracas when shaken. Maracas are a musical instrument that makes a sound when shaken thanks to the parts in its hollow body. It is also known as musical eggs, egg shakers, musical egg maracas, Easter egg percussion instruments. The visual and auditory nature of the musical egg can distract the child during the blood collection process.
| Study group | Role | What they receive |
|---|---|---|
| Rainstick Group | Experimental | Intervention Group-Rainstick Group: The rainstick method will be used as a non-pharmacological application for 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 and watch the sounds and movements and if they wish, they will be allowed to take the toy with their free hand. The rainstick will be cleaned with alcohol after being used on each child. The blood collection process will be performed by the nurse working in the blood collection unit. Receives: Other: Rain Stick |
| Musical Egg Group | Experimental | Intervention Group-Musical Egg Group: The musical egg method will be used as a non-pharmacological application for the children in this group. The children will be given a musical egg and during the blood collection process, the researcher or parent will turn it up and down and watch the sounds and movements and if they want, they will be allowed to take the toy with their free hand. The musical egg will be cleaned with alcohol after it is used on each child. The blood collection process will be done by the nurse working in the blood collection unit. Receives: Other: Musical Egg |
| Control Group | No intervention | The child will be taken to the blood collection room after being informed that the mother or father will be with him/her during the procedure. 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 routine blood collection. The blood collection will be performed by the nurse working in the blood collection unit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain During Blood Collection Procedure in Children
It is an unpleasant, emotional and sensory feeling that originates from any part of the body, is accompanied by real or potential tissue damage, and encompasses all past experiences of the patient.
Measured: "1 year"
Fear During Blood Collection Procedure in Children
It is a vital reaction that occurs as a stimulus response as a result of a specific pain or an event perceived as a threat.
Measured: "1 year"
Anxiety During Blood Collection Procedure in Children
It is a psychiatric disorder that causes intense anxiety and worry about possible future threats that are perceived but not present.
Measured: "1 year"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start22 Oct 2025
- Primary completion31 May 2026
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Procedural PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hakkari Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Demir Kösem, Hakkari Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06983093
- Sponsor's protocol ID
- HakkariOU
- Status last verified
- Jul 2026
- First submitted
- 26 Apr 2025
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06983093
- Acronym / sponsor ID
- HakkariOU
- Conditions
- Procedural Pain, Procedural Anxiety, Fear Needles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hakkari UniversitesiUniversity, hospital or other
- Study start
- 22 Oct 2025 (actual)
- Primary completion
- 31 May 2026 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Rainstick Group | Experimental | Other: Rain StickIntervention Group-Rainstick Group: The rainstick method will be used as a non-pharmacological application for 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 and watch the sounds and movements and if they wish, they will be allowed to take the toy with their free hand. The rainstick will be cleaned with alcohol after being used on each child. The blood collection process will be performed by the nurse working in the blood collection unit. |
| Musical Egg Group | Experimental | Other: Musical EggIntervention Group-Musical Egg Group: The musical egg method will be used as a non-pharmacological application for the children in this group. The children will be given a musical egg and during the blood collection process, the researcher or parent will turn it up and down and watch the sounds and movements and if they want, they will be allowed to take the toy with their free hand. The musical egg will be cleaned with alcohol after it is used on each child. The blood collection process will be done by the nurse working in the blood collection unit. |
| Control Group | No intervention | –The child will be taken to the blood collection room after being informed that the mother or father will be with him/her during the procedure. 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 routine blood collection. The blood collection will be performed by the nurse working in the blood collection unit. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rain StickThe rain stick to be used in the study is a toy made of wood, ranging in length from 20 to 120 cm. It is also a very entertaining musical instrument that imitates the sound of real rain. It is suitable for use by children aged 4 to 6. It has spiral shapes and colorful beads inside. When the rain stick is turned up and down, it produces a perfect rain sound that drizzles and patters. It is also known as a rain sound stick. The visual and auditory nature of the rain stick can distract the child during the blood collection process. | Other | Rainstick Group |
| Musical EggThe musical egg to be used in the study is a toy made of wood, approximately 6.5-7 cm in size. These wooden shaker eggs are a fun and interesting musical instrument. It is suitable for use by children aged 4-6. It is filled with iron sand and when shaken, it makes a clear sound and adds a unique rhythm to the music. This egg imitates the sound of maracas when shaken. Maracas are a musical instrument that makes a sound when shaken thanks to the parts in its hollow body. It is also known as musical eggs, egg shakers, musical egg maracas, Easter egg percussion instruments. The visual and auditory nature of the musical egg can distract the child during the blood collection process. | Other | Musical Egg Group |
Primary outcome
Pain During Blood Collection Procedure in Children
Time frame: "1 year"
It is an unpleasant, emotional and sensory feeling that originates from any part of the body, is accompanied by real or potential tissue damage, and encompasses all past experiences of the patient.
Fear During Blood Collection Procedure in Children
Time frame: "1 year"
It is a vital reaction that occurs as a stimulus response as a result of a specific pain or an event perceived as a threat.
Anxiety During Blood Collection Procedure in Children
Time frame: "1 year"
It is a psychiatric disorder that causes intense anxiety and worry about possible future threats that are perceived but not present.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rain Stick and Musical Egg in people with Procedural Pain and Procedural Anxiety, run by Hakkari Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain During Blood Collection Procedure in Children (time frame: "1 year"). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.