BloodlettingNCT05252494
The Effect Of Getting Children Between 3-6 To Watch Small Aquarium Fish On Physiological Parameters, Pain and Stress During Blood Collection
A study testing animal assisted therapy in people with Bloodletting, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial summary
Disease patterns are different from adults due to the fact that the abstract thinking and cause-effect abilities of children in the 3-6 age group are not developed. Children in this age group; Their ability to cope with stress is limited due to the need for special care, life experiences, mental development and… Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Bloodletting
- What is being tested?
- animal assisted therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2022to 30 Sep 2022
- 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 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parents' willingness to participate in the research is in line with the voluntary consent form have obtained written consent from their parents,
- The child is between 3-6 years old,
- The child musn't not have fish,
- No blood sampling has been performed in the last year,
- If the child is considered healthy as a result of the examination performed by the doctor,
Who cannot join
- if The child has fish
- To have taken analgesic medication 4 hours before the procedure
- if The child is afraid of fish,
- The child has a known allergy history,
- Deterioration of skin integrity in the blood collection area,
- ifThe child has a visual/hearing disability.
- if The child has developmental delay, mental problems
- if there is Failure of blood collection in the first attempt.
Trial locations and contacts
1 site in 1 country.
About this study
Disease patterns are different from adults due to the fact that the abstract thinking and cause-effect abilities of children in the 3-6 age group are not developed. Children in this age group; Their ability to cope with stress is limited due to the need for special care, life experiences, mental development and inadequate ability to express themselves verbally (Conk et al, 2013). Illness is a source of pain and stress for them due to external factors and is a punishment for their bad behavior (Conk et al, 2013; Teksöz \& Ocakçı, 2014).Hospital, on the other hand, means foreign environment/persons, loss of independence, loss of privacy, painful procedures, disruption of daily routines, surgery, pain, disability, death, separation from family and friends for children (Conk et al, 2013). Blood collection and vascular access are the interventions that cause the most pain, stress and anxiety in hospitalized children (Duff, 2003; Caprilli et al, 2007) . Non-invasive non-pharmacological methods increase the release of endorphins, the body's natural morphine, and relieve pain, thereby reducing the stress and anxiety of the child and family (Bergomi et al, 2018). Clinical experience argues that human-animal bonding, which is one of the distraction practices in pain management, is effective in reducing pain and stress (Muslu, 2011; Min \& Zaw 2016; Alvarez et al, 2020) .
In the light of all this information; The aim of this study was to determine the effect of watching small aquarium fish, which is used as a distraction method during the blood collection process, on the pain and stress, heart rate and oxygen saturation during the procedure in children aged 3-6 years who applied to the blood collection unit.
Read more
Hypotheses of the Research:
Hypothesis 0 (H0): Feelings felt by children watching and not watching fish during blood collection there was no difference between stress, pain score, heart rate, oxygen saturation, crying and procedure time.
Hypothesis 1 (H1): The oxygen saturation of the children who watched the fish during the blood collection process is high.
Hypothesis 2 (H2): Children watching the fish during the blood draw have a higher heart rate is low.
Hypothesis 3 (H3): Children who watched the fish during the blood draw had a higher pain score is low.
Hypothesis 4 (H4): The stress score of the children who watched the fish during the blood collection process was higher is low.
Hypothesis 5 (H5): The crying time of the children watching the fish during the blood collection process is longer is short.
Hypothesis 6 (H6): The processing time is longer for children watching the fish during the blood collection process is short.
Read the detailed description
The universe of the research will be all children brought to a training and research hospital for blood transfusion between March 2022 and March 2023. The sample of the study will be the children of parents who comply with the sample selection criteria and volunteer to participate in the research.
In order to determine the number of samples, power analysis was performed using the G*Power (v3.1.7) program. The power of the study is expressed as 1-β (β = probability of type II error), and in general studies should have 80% power. Based on the pain measurement differences before and after the procedure in Carie Braun's study to evaluate the pain during blood collection (difference of the means for the control group: 0.31; the difference of the mean for the experimental group was 1.61), the effect size was calculated to obtain 80% power at the α=0.05 level. (d) 0.748 was found. According to this, it was calculated that there should be at least 30 people in each group and 60 people in total. Considering that there may be losses during the study process, it was decided to take at least 35 people in each group.
Data Collection Tools and Materials: The following tools and forms will be used in the collection of research data: Informed Voluntary Consent Form (Appendix 1): Before starting the research, all children's parents should be informed about the purpose, plan, duration of the research, how the obtained data will be used "Voluntary Information and Consent Form" " and verbal and written permissions will be obtained. Parents who agree to participate in the study will be told that they can withdraw from the study at any time, they will be assured that the individual information obtained will not be disclosed to anyone other than the researcher, and that no fees will be charged to the parents or that no research expense will be charged to the social security institution to which the patient is affiliated.
Information Form (Appendix 2): It was prepared by scanning the literature on the subject. The information form is the form in which the child's name, surname, group, introductory information about the parents and the child are recorded. The information form will be filled by the researcher himself by face-to-face interview method. Follow-up Form (Appendix 3): It was prepared by scanning the literature on the subject. The follow-up form is the form in which the child's pain and stress score, physiological parameters, crying and duration of the procedure are recorded. The follow-up form will be filled in by the researcher himself in line with the findings obtained from the patient during data collection.
Pain Assessment Tool (FLACC) (Appendix 4):
It was developed by Merkel (1997), and Turkish validity and reliability was done by Şenaylı et al (2006). Each of the baby's facial expression, leg movements, activity, crying and comfortability parameters consists of three sub-items and can be applied to children aged 1 month to 9 years. The items take the value 0, 1, 2, respectively, and the total score is between 0 and 10. A "0" score indicates no pain, 1-3 points mild, 4-6 points moderate and 7-10 points severe pain. In order to use the FLACC pain assessment scale, permission was obtained from Şenaylı et al. via e-mail.
Wong and Baker Faces Pain Scale [Wong-Baker Faces Pain Rating Scale (WBFPRS) (Appendix 5): This scale was developed by Donna Wong and Connie Morain Baker in 1988. This scale is used to diagnose pain in children aged 3-18 years. Studies comparing this tool with others have reported that children like the facial expressions rating scale and that it provides the most accurate pain measurement. In this scale, pain scores are given according to the numerical values given to the faces. The lowest score is "1" and the highest score is "5". As the score obtained from the scale increases, the pain tolerance decreases, and as the score decreases, the tolerance increases.
Children's Emotional Manifestation Scale-CEMS (Appendix 6): Children's Emotional Expression Evaluation Scale; The scale, which was developed by Ho Cheung William Li (Children's Emotional Manifestation Scale-CEMS) in 2003 and validated in Turkish by Yanık and Ark (2019), consists of a total of 5 different categories and 25 items. This scale evaluates the anxiety experienced by children during medical procedures. In the facial expression category of the first 5 items, the facial expressions of the child observed by the researcher are scored. Secondly, the child's tear state is evaluated over 5 sub-items in the vocalization category. Third, in the 5 sub-items of the movement title, the child's body language is scored. Fourth, the child's verbal or non-verbal communication is evaluated in 5 sub-items in the interaction category. Fifth, scoring is done by observing the active or passive participation of the child in the 5 sub-items of the cooperation category. 1-5 points in each category
- Conditions
- Bloodletting
- Being tested
- animal assisted therapy
- Keywords
- Pain management, animal assisted therapy, Aquarium Fish, Blood Collection, Physiological Parameters, Stress
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
animal assisted therapyOther
In the intervention group, the child will be given to the mother's lap just before the invasive procedure. During the process, the aquarium with the fish will be placed on a shelf at a distance of about 50-60 cm, at an angle that the child can see. The camera on which the blood collection will be recorded will be placed on a tripod and placed on another shelf in such a way that the child can be seen completely. A video recording will be started 1 minute before the procedure, a pulse oximeter device will be attached to the child immediately after the child is seated on his mother's lap, physiological parameters, pain scores and stress will be determined. During the procedure, children's physiological measurements pain score and stress will be re-evaluated after the needle is inserted into the site. After the procedure, children's physiological measurements pain score and stress will be re-evaluated 1 minute after the needle is removed from the injection site
| Study group | Role | What they receive |
|---|---|---|
| animal assisted therapy group | Experimental | Animal assisted therapy group will watch aquarium fish while bloodletting prosedure. Receives: Other: animal assisted therapy |
| Control Group | No intervention | Control group will not watch aquarium fish while bloodletting prosedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in physiological parameters
Differences in oxygen saturation
Measured: 1 year
Differences in physiological parameters
Differences in heart rate
Measured: 1 year
Differences in pain score
Pain Assessment Tool (FLACC):
The items take the value 0, 1, 2, respectively, and the total score is between 0 and 10. A "0" score indicates no pain, 1-3 points mild, 4-6 points moderate and 7-10 points severe pain.
Measured: 1 year
Differences in pain score
Wong and Baker Faces Pain Scale [Wong-Baker Faces Pain Rating Scale (WBFPRS): The lowest score is "1" and the highest score is "5". As the score obtained from the scale increases, the pain tolerance decreases, and as the score decreases, the tolerance increases.
Measured: 1 year
Differences in stress
Children's Emotional Manifestation Scale-CEMS: Scale consists of a total of 5 different categories and 25 items. As the score obtained from the scale increases, the pain tolerance decreases, and as the score decreases, the tolerance increases.
Measured: 1 year
Differences in crying time
Crying time will be measured by chronometer (second/minute)
Measured: 1 year
Differences in procedure time
Prosedure time will be measured by chronometer (second/minute)
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 posted23 Feb 2022
- Study start1 Mar 2022
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for BloodlettingStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The research consists of 2 groups as experimental and control group. In the experimental group, the children who watched the fish during the bloodletting process comprised the animal-assisted treatment group, and the control group consisted of the children who underwent routine bloodletting.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tugba KARAKUS TURKER, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05252494
- Sponsor's protocol ID
- UskudarUskudar
- Status last verified
- Jul 2026
- First submitted
- 11 Jan 2022
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Teksöz, E. Ocakçı, A. F. Çocuk Hemşireliği'nde Sanat Uygulamaları. Dokuz Eylül Üniversitesi Hemşirelik Fakültesi Dergisi.2014; 7(2): 119- 123.
Duff AJ. Incorporating psychological approaches into routine paediatric venepuncture. Arch Dis Child. 2003 Oct;88(10):931-7. doi: 10.1136/adc.88.10.931.
PubMed 14500318Bergomi P, Scudeller L, Pintaldi S, Dal Molin A. Efficacy of Non-pharmacological Methods of Pain Management in Children Undergoing Venipuncture in a Pediatric Outpatient Clinic: A Randomized Controlled Trial of Audiovisual Distraction and External Cold and Vibration. J Pediatr Nurs. 2018 Sep-Oct;42:e66-e72. doi: 10.1016/j.pedn.2018.04.011. Epub 2018 May 1.
PubMed 29728296Caprilli S, Anastasi F, Grotto RP, Scollo Abeti M, Messeri A. Interactive music as a treatment for pain and stress in children during venipuncture: a randomized prospective study. J Dev Behav Pediatr. 2007 Oct;28(5):399-403. doi: 10.1097/DBP.0b013e31811ff8a7.
PubMed 18049324Muslu, G. K. Conk, K. Hayvan Destekli Uygulamalar Ve Çocuklarda Kullanımı. Deuhyo Ed 2011, 4 (2), 83-88.
Min, M. Zaw, C.C. A Review On Animal-Assisted Therapy And Activities For Healthcare And Teaching Of Children. Journal Of Education And Social Sciences.2016;(3), 40-46.
Avila-Alvarez A, Pardo-Vazquez J, De-Rosende-Celeiro I, Jacome-Feijoo R, Torres-Tobio G. Assessing the Outcomes of an Animal-Assisted Intervention in a Paediatric Day Hospital: Perceptions of Children and Parents. Animals (Basel). 2020 Oct 1;10(10):1788. doi: 10.3390/ani10101788.
PubMed 33019696Conk Z, Başbakkal Z, Bal Yılmaz H, Bolışık B. Pediatri Hemşireliği. Akademisyen Tıp Kitabevi, Ankara, 2013.
Braun C, Stangler T, Narveson J, Pettingell S. Animal-assisted therapy as a pain relief intervention for children. Complement Ther Clin Pract. 2009 May;15(2):105-9. doi: 10.1016/j.ctcp.2009.02.008. Epub 2009 Mar 3.
PubMed 19341990Yanık, M. Kuzlu Ayyıldız, T. Kulakçı Altıntaş, H. Çocukların Duygusal Dışa Vurumunu Değerlendirme Ölçeği: Geçerlik Ve Güvenirlik Çalışması. Anadolu Hemşirelik Ve Sağlık Bilimleri Dergisi, 2019; 22(3): 179-188
Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7.
PubMed 9220806Şenaylı, Y. Özkan, F. Şenaylı, A. Bıçakçı, Ü. Çocuklarda Postoperatif Ağrının FLACC (YBAAT) Ağrı Skalasıyla Değerlendirilmesi. Turkiye Klinikleri J Anest Reanim. 2006;4(1):1-4
Wong DL, Baker CM. Pain in children: comparison of assessment scales. Pediatr Nurs. 1988 Jan-Feb;14(1):9-17. No abstract available.
PubMed 3344163
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
- The Effect Of Getting Children Between 3-6 To Watch Small Aquarium Fish On Physiological Parameters, Pain and Stress During Blood Collection
- ClinicalTrials.gov ID
- NCT05252494
- Acronym / sponsor ID
- UskudarUskudar
- Conditions
- Bloodletting
- Keywords
- Pain management, animal assisted therapy, Aquarium Fish, Blood Collection, Physiological Parameters, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 23 Feb 2022 (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.
Disease patterns are different from adults due to the fact that the abstract thinking and cause-effect abilities of children in the 3-6 age group are not developed. Children in this age group; Their ability to cope with stress is limited due to the need for special care, life experiences, mental development and inadequate ability to express themselves verbally (Conk et al, 2013). Illness is a source of pain and stress for them due to external factors and is a punishment for their bad behavior (Conk et al, 2013; Teksöz \& Ocakçı, 2014).Hospital, on the other hand, means foreign environment/persons, loss of independence, loss of privacy, painful procedures, disruption of daily routines, surgery, pain, disability, death, separation from family and friends for children (Conk et al, 2013). Blood collection and vascular access are the interventions that cause the most pain, stress and anxiety in hospitalized children (Duff, 2003; Caprilli et al, 2007) . Non-invasive non-pharmacological methods increase the release of endorphins, the body's natural morphine, and relieve pain, thereby reducing the stress and anxiety of the child and family (Bergomi et al, 2018). Clinical experience argues that human-animal bonding, which is one of the distraction practices in pain management, is effective in reducing pain and stress (Muslu, 2011; Min \& Zaw 2016; Alvarez et al, 2020) .
In the light of all this information; The aim of this study was to determine the effect of watching small aquarium fish, which is used as a distraction method during the blood collection process, on the pain and stress, heart rate and oxygen saturation during the procedure in children aged 3-6 years who applied to the blood collection unit.
Hypotheses of the Research:
Hypothesis 0 (H0): Feelings felt by children watching and not watching fish during blood collection there was no difference between stress, pain score, heart rate, oxygen saturation, crying and procedure time.
Hypothesis 1 (H1): The oxygen saturation of the children who watched the fish during the blood collection process is high.
Hypothesis 2 (H2): Children watching the fish during the blood draw have a higher heart rate is low.
Hypothesis 3 (H3): Children who watched the fish during the blood draw had a higher pain score is low.
Hypothesis 4 (H4): The stress score of the children who watched the fish during the blood collection process was higher is low.
Hypothesis 5 (H5): The crying time of the children watching the fish during the blood collection process is longer is short.
Hypothesis 6 (H6): The processing time is longer for children watching the fish during the blood collection process is short.
Detailed description
The universe of the research will be all children brought to a training and research hospital for blood transfusion between March 2022 and March 2023. The sample of the study will be the children of parents who comply with the sample selection criteria and volunteer to participate in the research.
In order to determine the number of samples, power analysis was performed using the G*Power (v3.1.7) program. The power of the study is expressed as 1-β (β = probability of type II error), and in general studies should have 80% power. Based on the pain measurement differences before and after the procedure in Carie Braun's study to evaluate the pain during blood collection (difference of the means for the control group: 0.31; the difference of the mean for the experimental group was 1.61), the effect size was calculated to obtain 80% power at the α=0.05 level. (d) 0.748 was found. According to this, it was calculated that there should be at least 30 people in each group and 60 people in total. Considering that there may be losses during the study process, it was decided to take at least 35 people in each group.
Data Collection Tools and Materials: The following tools and forms will be used in the collection of research data: Informed Voluntary Consent Form (Appendix 1): Before starting the research, all children's parents should be informed about the purpose, plan, duration of the research, how the obtained data will be used "Voluntary Information and Consent Form" " and verbal and written permissions will be obtained. Parents who agree to participate in the study will be told that they can withdraw from the study at any time, they will be assured that the individual information obtained will not be disclosed to anyone other than the researcher, and that no fees will be charged to the parents or that no research expense will be charged to the social security institution to which the patient is affiliated.
Information Form (Appendix 2): It was prepared by scanning the literature on the subject. The information form is the form in which the child's name, surname, group, introductory information about the parents and the child are recorded. The information form will be filled by the researcher himself by face-to-face interview method. Follow-up Form (Appendix 3): It was prepared by scanning the literature on the subject. The follow-up form is the form in which the child's pain and stress score, physiological parameters, crying and duration of the procedure are recorded. The follow-up form will be filled in by the researcher himself in line with the findings obtained from the patient during data collection.
Pain Assessment Tool (FLACC) (Appendix 4):
It was developed by Merkel (1997), and Turkish validity and reliability was done by Şenaylı et al (2006). Each of the baby's facial expression, leg movements, activity, crying and comfortability parameters consists of three sub-items and can be applied to children aged 1 month to 9 years. The items take the value 0, 1, 2, respectively, and the total score is between 0 and 10. A "0" score indicates no pain, 1-3 points mild, 4-6 points moderate and 7-10 points severe pain. In order to use the FLACC pain assessment scale, permission was obtained from Şenaylı et al. via e-mail.
Wong and Baker Faces Pain Scale [Wong-Baker Faces Pain Rating Scale (WBFPRS) (Appendix 5): This scale was developed by Donna Wong and Connie Morain Baker in 1988. This scale is used to diagnose pain in children aged 3-18 years. Studies comparing this tool with others have reported that children like the facial expressions rating scale and that it provides the most accurate pain measurement. In this scale, pain scores are given according to the numerical values given to the faces. The lowest score is "1" and the highest score is "5". As the score obtained from the scale increases, the pain tolerance decreases, and as the score decreases, the tolerance increases.
Children's Emotional Manifestation Scale-CEMS (Appendix 6): Children's Emotional Expression Evaluation Scale; The scale, which was developed by Ho Cheung William Li (Children's Emotional Manifestation Scale-CEMS) in 2003 and validated in Turkish by Yanık and Ark (2019), consists of a total of 5 different categories and 25 items. This scale evaluates the anxiety experienced by children during medical procedures. In the facial expression category of the first 5 items, the facial expressions of the child observed by the researcher are scored. Secondly, the child's tear state is evaluated over 5 sub-items in the vocalization category. Third, in the 5 sub-items of the movement title, the child's body language is scored. Fourth, the child's verbal or non-verbal communication is evaluated in 5 sub-items in the interaction category. Fifth, scoring is done by observing the active or passive participation of the child in the 5 sub-items of the cooperation category. 1-5 points in each category
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The research consists of 2 groups as experimental and control group. In the experimental group, the children who watched the fish during the bloodletting process comprised the animal-assisted treatment group, and the control group consisted of the children who underwent routine bloodletting.
| Arm | Type | Receives |
|---|---|---|
| animal assisted therapy group | Experimental | Other: animal assisted therapyAnimal assisted therapy group will watch aquarium fish while bloodletting prosedure. |
| Control Group | No intervention | –Control group will not watch aquarium fish while bloodletting prosedure. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Parents' willingness to participate in the research is in line with the voluntary consent form have obtained written consent from their parents,
- The child is between 3-6 years old,
- The child musn't not have fish,
- No blood sampling has been performed in the last year,
- If the child is considered healthy as a result of the examination performed by the doctor,
Key exclusion criteria (8 listed)
- if The child has fish
- To have taken analgesic medication 4 hours before the procedure
- if The child is afraid of fish,
- The child has a known allergy history,
- Deterioration of skin integrity in the blood collection area,
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 |
|---|---|---|
| animal assisted therapyIn the intervention group, the child will be given to the mother's lap just before the invasive procedure. During the process, the aquarium with the fish will be placed on a shelf at a distance of about 50-60 cm, at an angle that the child can see. The camera on which the blood collection will be recorded will be placed on a tripod and placed on another shelf in such a way that the child can be seen completely. A video recording will be started 1 minute before the procedure, a pulse oximeter device will be attached to the child immediately after the child is seated on his mother's lap, physiological parameters, pain scores and stress will be determined. During the procedure, children's physiological measurements pain score and stress will be re-evaluated after the needle is inserted into the site. After the procedure, children's physiological measurements pain score and stress will be re-evaluated 1 minute after the needle is removed from the injection site | Other | animal assisted therapy group |
Primary outcome
Differences in physiological parameters
Time frame: 1 year
Differences in oxygen saturation
Differences in physiological parameters
Time frame: 1 year
Differences in heart rate
Differences in pain score
Time frame: 1 year
Pain Assessment Tool (FLACC): The items take the value 0, 1, 2, respectively, and the total score is between 0 and 10. A "0" score indicates no pain, 1-3 points mild, 4-6 points moderate and 7-10 points severe pain.
Differences in pain score
Time frame: 1 year
Wong and Baker Faces Pain Scale [Wong-Baker Faces Pain Rating Scale (WBFPRS): The lowest score is "1" and the highest score is "5". As the score obtained from the scale increases, the pain tolerance decreases, and as the score decreases, the tolerance increases.
Differences in stress
Time frame: 1 year
Children's Emotional Manifestation Scale-CEMS: Scale consists of a total of 5 different categories and 25 items. As the score obtained from the scale increases, the pain tolerance decreases, and as the score decreases, the tolerance increases.
Differences in crying time
Time frame: 1 year
Crying time will be measured by chronometer (second/minute)
Differences in procedure time
Time frame: 1 year
Prosedure time will be measured by chronometer (second/minute)
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.
- BackgroundTeksöz, E. Ocakçı, A. F. Çocuk Hemşireliği'nde Sanat Uygulamaları. Dokuz Eylül Üniversitesi Hemşirelik Fakültesi Dergisi.2014; 7(2): 119- 123.
- Background: PubMed 14500318Duff AJ. Incorporating psychological approaches into routine paediatric venepuncture. Arch Dis Child. 2003 Oct;88(10):931-7. doi: 10.1136/adc.88.10.931.
- Background: PubMed 29728296Bergomi P, Scudeller L, Pintaldi S, Dal Molin A. Efficacy of Non-pharmacological Methods of Pain Management in Children Undergoing Venipuncture in a Pediatric Outpatient Clinic: A Randomized Controlled Trial of Audiovisual Distraction and External Cold and Vibration. J Pediatr Nurs. 2018 Sep-Oct;42:e66-e72. doi: 10.1016/j.pedn.2018.04.011. Epub 2018 May 1.
- Background: PubMed 18049324Caprilli S, Anastasi F, Grotto RP, Scollo Abeti M, Messeri A. Interactive music as a treatment for pain and stress in children during venipuncture: a randomized prospective study. J Dev Behav Pediatr. 2007 Oct;28(5):399-403. doi: 10.1097/DBP.0b013e31811ff8a7.
- BackgroundMuslu, G. K. Conk, K. Hayvan Destekli Uygulamalar Ve Çocuklarda Kullanımı. Deuhyo Ed 2011, 4 (2), 83-88.
- BackgroundMin, M. Zaw, C.C. A Review On Animal-Assisted Therapy And Activities For Healthcare And Teaching Of Children. Journal Of Education And Social Sciences.2016;(3), 40-46.
- Background: PubMed 33019696Avila-Alvarez A, Pardo-Vazquez J, De-Rosende-Celeiro I, Jacome-Feijoo R, Torres-Tobio G. Assessing the Outcomes of an Animal-Assisted Intervention in a Paediatric Day Hospital: Perceptions of Children and Parents. Animals (Basel). 2020 Oct 1;10(10):1788. doi: 10.3390/ani10101788.
- BackgroundConk Z, Başbakkal Z, Bal Yılmaz H, Bolışık B. Pediatri Hemşireliği. Akademisyen Tıp Kitabevi, Ankara, 2013.
- Background: PubMed 19341990Braun C, Stangler T, Narveson J, Pettingell S. Animal-assisted therapy as a pain relief intervention for children. Complement Ther Clin Pract. 2009 May;15(2):105-9. doi: 10.1016/j.ctcp.2009.02.008. Epub 2009 Mar 3.
- BackgroundYanık, M. Kuzlu Ayyıldız, T. Kulakçı Altıntaş, H. Çocukların Duygusal Dışa Vurumunu Değerlendirme Ölçeği: Geçerlik Ve Güvenirlik Çalışması. Anadolu Hemşirelik Ve Sağlık Bilimleri Dergisi, 2019; 22(3): 179-188
- Background: PubMed 9220806Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7.
- BackgroundŞenaylı, Y. Özkan, F. Şenaylı, A. Bıçakçı, Ü. Çocuklarda Postoperatif Ağrının FLACC (YBAAT) Ağrı Skalasıyla Değerlendirilmesi. Turkiye Klinikleri J Anest Reanim. 2006;4(1):1-4
- 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 animal assisted therapy in people with Bloodletting, run by Uskudar University 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 8 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?
Differences in physiological parameters (time frame: 1 year). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05252494, which also lists 13 linked publications.
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.