PainNCT06600763
Ice Pack and Lukewarm Gel Pad Use on Pain, Anxiety Level and Physiological Parameters
A study testing Ice pack and warm gel pad in people with Pain and Anxiety, run by Tarsus University.
Trial summary
The study was planned as a randomized controlled experimental study to determine the effect of cold application used during surgical drain removal on pain, anxiety level and physiological parameters of children aged 9-18 years. Read more about this study
- Who is it for?
- Ages 9 to 18 years
- What is being tested?
- Ice pack and warm gel pad
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2024to 31 May 2025
- 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 9 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- The child must be between the ages of 9 and 18,
- The child does not have developmental delay (Developmental Problems: Delay in one or more of the developmental areas such as communication, social-emotional, cognitive, sensory functions, fine-rough movements, self-care, loss of function, loss of ability, loss of ability, limitation of participation in life as a result of disease)
- Follow-up with surgical drain
- The child does not have a chronic disease that may affect his/her life
- Voluntariness of the parent and child to participate in the study
Who cannot join
- The child is under 9 years of age
- Communication problems
- Not volunteering to participate in the study
- Presence of more than one surgical drain
- The presence of developmental delay in the child (Developmental Problems: Delay in one or more of the developmental areas such as communication, social-emotional, cognitive, sensory functions, fine-rude movements, self-care, loss of function, loss of ability, loss of ability, restriction of participation in life as a result of disease)
- Previous surgical procedure under general anesthesia
- Use of any analgesic medication until at least 6 hours before the procedure
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Ice Pack and Lukewarm Gel Pad Use on Pain, Anxiety Level and Physiological Parameters of the Child During Surgical Drain Removal in Children Aged 9-18 Years
The study was planned as a randomized controlled experimental study to determine the effect of cold application used during surgical drain removal on pain, anxiety level and physiological parameters of children aged 9-18 years.
The study will be conducted between July 2024 and April 2025 in the Pediatric Surgery Service of Adana City Training and Research Hospital. Pediatric Surgery Service has a capacity of 24 beds and 14 nurses work on a roster basis with 5 nurses during the day and 3 nurses at night. The clinical physician staff consists of 8 pediatric surgery specialists and 1 pediatric urologist. Mostly, acute abdomen, intra-abdominal mass excision, hypospadias surgery and congenital megacolon surgeries are performed.
Read more
The clinic provides outpatient and emergency services on a 24/7 basis. Data Collection In the study, children treated in pediatric surgery and followed up with drainage system after abdominal surgery will be evaluated in terms of sampling criteria and children who do not meet the criteria will be excluded from the study.
Application
- Phase: The necessary ethics committee and institutional permission will be obtained before starting the study.
- Stage: The decision to remove the drainage system after the end of function or end of indication is communicated to the investigator by the physician.
- Stage: After obtaining written informed consent from the child\'s parents for the drain removal procedure, the researcher will explain the drain removal procedure and what will be done during the procedure to the parents. Then the descriptive information form will be filled.
- Stage: Physiological parameters (pulse, blood pressure, respiration, SPO2 ) of the children will be measured by the researcher before and after the procedure.
- Before the procedure, the necessary materials (ice pack or warm gel ice, infrared thermometer, gloves, saline, scalpel, clamp, sterile sponge, plaster and scissors) will be prepared and the drainage system will be clamped.
- The parent and nurse will assess and record the child\'s pain score 15 minutes before, during and 15 minutes after the procedure. The child will be asked to make the same assessments and the results will be recorded.
Read the detailed description
Non-pharmacologic methods can be used to reduce pain during drain removal. One of these methods is cold application. Cold application shows a local anesthetic effect in the application area by increasing the release of endogenous opioids by stimulating touch receptors based on the gate control theory and the pain felt is reduced as a result of these mechanisms.
It is thought that ice pack and warm gel ice applications to be used during drain removal in pediatric patients may be a non-pharmacologic method for surgical drain removal and will contribute to comprehensive research on this subject.
The study was planned as a randomized controlled experimental study to determine the effect of cold application used during surgical drain removal on pain, anxiety level and physiological parameters of children aged 9-18 years.
The study will be conducted between July 2024 and April 2025 in the Pediatric Surgery Service of Adana City Training and Research Hospital. Pediatric Surgery Service has a capacity of 24 beds and 14 nurses work on a roster basis with 5 nurses during the day and 3 nurses at night. The clinical physician staff consists of 8 pediatric surgery specialists and 1 pediatric urologist. Mostly, acute abdomen, intra-abdominal mass excision, hypospadias surgery and congenital megacolon surgeries are performed.
The clinic provides outpatient and emergency services on a 24/7 basis. Data Collection In the study, children treated in pediatric surgery and followed up with drainage system after abdominal surgery will be evaluated in terms of sampling criteria and children who do not meet the criteria will be excluded from the study.
Application
- Phase: The necessary ethics committee and institutional permission will be obtained before starting the study.
- Stage: The decision to remove the drainage system after the end of function or end of indication is communicated to the investigator by the physician.
- Stage: After obtaining written informed consent from the child\'s parents for the drain removal procedure, the researcher will explain the drain removal procedure and what will be done during the procedure to the parents. Then the descriptive information form will be filled.
- Stage: Physiological parameters (pulse, blood pressure, respiration, SPO2 ) of the children will be measured by the researcher before and after the procedure.
- Before the procedure, the necessary materials (ice pack or warm gel ice, infrared thermometer, gloves, saline, scalpel, clamp, sterile sponge, plaster and scissors) will be prepared and the drainage system will be clamped.
- The parent and nurse will assess and record the child pain score 15 minutes before, during and 15 minutes after the procedure. The child will be asked to make the same assessments and the results will be recorded.
Ice pack application group: An ice pack kept in the refrigerator and having a temperature of -10 degrees Celsius will be wrapped in sterile gauze and applied to the drain area of the pediatric patient who is decided to end the surgical drain indication. The temperature of the area where the ice pack is applied will be measured at one minute intervals, and when the relevant area reaches a temperature of 13.6 0C, the physician will be informed and the drain removal procedure will be initiated. The child will be asked to mark the degree of pain felt before, during and after the procedure.
Warm gel pad application group: Gel pads kept at room temperature will be applied to the drain area of the pediatric patient whose surgical drain indication is decided to end, in a sheath designed to wrap around the drain. After waiting for 10 minutes in the application area, the drainage system will be removed by the physician.
Control group: The integrated drainage system will be withdrawn by the physician. The child will not receive any non-pharmacologic intervention before, during or after the procedure.
- Being tested
- Ice pack, warm gel pad
- Keywords
- pain, anxiety, children, surgery
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ice packOther
The temperature of the area where the ice pack is applied will be measured at one minute intervals, and when the relevant area reaches a temperature of 13.6 0C, the physician will be informed and the drain removal procedure will be initiated.
warm gel padOther
Gel pads kept at room temperature will be applied to the drain area of the pediatric patient whose surgical drain indication is decided to end, in a sheath designed to wrap around the drain. After waiting for 10 minutes in the application area, the drainage system will be removed by the physician.
| Study group | Role | What they receive |
|---|---|---|
| Ice pack | Experimental | Ice pack application group: An ice pack kept in the refrigerator and having a temperature of -10 degrees Celsius will be wrapped in sterile gauze and applied to the drain area of the pediatric patient who is decided to end the surgical drain indication. The temperature of the area where the ice pack is applied will be measured at one minute intervals, and when the relevant area reaches a temperature of 13.6 0C, the physician will be informed and the drain removal procedure will be initiated. The child will be asked to mark the degree of pain felt before, during and after the procedure. Receives: Other: Ice pack |
| warm gel | Experimental | Warm gel pad application group: Gel pads kept at room temperature will be applied to the drain area of the pediatric patient whose surgical drain indication is decided to end, in a sheath designed to wrap around the drain. After waiting for 10 minutes in the application area, the drainage system will be removed by the physician. Receives: Other: warm gel pad |
| Control | No intervention | Control group: The integrated drainage system will be withdrawn by the physician. The child will not receive any non-pharmacologic intervention before, during or after the procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
State-Trait Continuity Inventory for Children
State-Trait Continuity Inventory for Children : The inventory, which is used to measure the state and trait anxiety states of children, was developed by Spielberger in 1973. It is a simplified form of the State-Trait Anxiety Inventory developed for adults for children. While the number of options was 4 in the adult form, it was reduced to 3 in the child form. Özusta translated the inventory into Turkish and conducted an application study.
Measured: 1 hour
Pain level
Numerical Pain Scale : This method, which aims to determine the severity of pain, aims to explain the patient\'s pain in numbers. On numerical scales, absence of pain (0) is evaluated as unbearable pain (10).
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start20 Sep 2024 (estimated)
- Primary completion25 Feb 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tarsus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdurrahman Başkurt, Tarsus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06600763
- Sponsor's protocol ID
- 2024/82
- Status last verified
- Sep 2024
- First submitted
- 16 Sep 2024
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Simsek Yaban Z, Alvarez-Garcia C, Bozdemir H. The effect of cold application on pain during the chest tube removal: A meta-analysis. Turk Gogus Kalp Damar Cerrahisi Derg. 2023 Jul 27;31(3):398-407. doi: 10.5606/tgkdc.dergisi.2023.23846. eCollection 2023 Jul.
PubMed 37664777Kazan AGDEE. (2011). Soğuk Uygulamalar ve Hemşirelik Bakımı. HUHEMFAD. 18(1):73-82.
Knowlton MC. Nurse's guide to surgical drain removal. Nursing. 2015 Sep;45(9):59-61. doi: 10.1097/01.NURSE.0000470418.02063.ca. No abstract available.
PubMed 26287712Özveren, H. (2011). Ağrı kontrolünde farmakolojik olmayan yöntemler. Sağlık Bilimleri Fakültesi Hemşirelik Dergisi, 18(1), 83-92.
Ertug N, Ulker S. The effect of cold application on pain due to chest tube removal. J Clin Nurs. 2012 Mar;21(5-6):784-90. doi: 10.1111/j.1365-2702.2011.03955.x. Epub 2011 Nov 15.
PubMed 22082021
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ice Pack and Lukewarm Gel Pad Use on Pain, Anxiety Level and Physiological Parameters of the Child During Surgical Drain Removal in Children Aged 9-18 Years
- ClinicalTrials.gov ID
- NCT06600763
- Acronym / sponsor ID
- 2024/82
- Keywords
- pain, anxiety, children, surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Tarsus UniversityUniversity, hospital or other
- Study start
- 20 Sep 2024 (estimated)
- Primary completion
- 25 Feb 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 19 Sep 2024 (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.
The study was planned as a randomized controlled experimental study to determine the effect of cold application used during surgical drain removal on pain, anxiety level and physiological parameters of children aged 9-18 years.
The study will be conducted between July 2024 and April 2025 in the Pediatric Surgery Service of Adana City Training and Research Hospital. Pediatric Surgery Service has a capacity of 24 beds and 14 nurses work on a roster basis with 5 nurses during the day and 3 nurses at night. The clinical physician staff consists of 8 pediatric surgery specialists and 1 pediatric urologist. Mostly, acute abdomen, intra-abdominal mass excision, hypospadias surgery and congenital megacolon surgeries are performed.
The clinic provides outpatient and emergency services on a 24/7 basis. Data Collection In the study, children treated in pediatric surgery and followed up with drainage system after abdominal surgery will be evaluated in terms of sampling criteria and children who do not meet the criteria will be excluded from the study.
Application
- Phase: The necessary ethics committee and institutional permission will be obtained before starting the study.
- Stage: The decision to remove the drainage system after the end of function or end of indication is communicated to the investigator by the physician.
- Stage: After obtaining written informed consent from the child\'s parents for the drain removal procedure, the researcher will explain the drain removal procedure and what will be done during the procedure to the parents. Then the descriptive information form will be filled.
- Stage: Physiological parameters (pulse, blood pressure, respiration, SPO2 ) of the children will be measured by the researcher before and after the procedure.
- Before the procedure, the necessary materials (ice pack or warm gel ice, infrared thermometer, gloves, saline, scalpel, clamp, sterile sponge, plaster and scissors) will be prepared and the drainage system will be clamped.
- The parent and nurse will assess and record the child\'s pain score 15 minutes before, during and 15 minutes after the procedure. The child will be asked to make the same assessments and the results will be recorded.
Detailed description
Non-pharmacologic methods can be used to reduce pain during drain removal. One of these methods is cold application. Cold application shows a local anesthetic effect in the application area by increasing the release of endogenous opioids by stimulating touch receptors based on the gate control theory and the pain felt is reduced as a result of these mechanisms.
It is thought that ice pack and warm gel ice applications to be used during drain removal in pediatric patients may be a non-pharmacologic method for surgical drain removal and will contribute to comprehensive research on this subject.
The study was planned as a randomized controlled experimental study to determine the effect of cold application used during surgical drain removal on pain, anxiety level and physiological parameters of children aged 9-18 years.
The study will be conducted between July 2024 and April 2025 in the Pediatric Surgery Service of Adana City Training and Research Hospital. Pediatric Surgery Service has a capacity of 24 beds and 14 nurses work on a roster basis with 5 nurses during the day and 3 nurses at night. The clinical physician staff consists of 8 pediatric surgery specialists and 1 pediatric urologist. Mostly, acute abdomen, intra-abdominal mass excision, hypospadias surgery and congenital megacolon surgeries are performed.
The clinic provides outpatient and emergency services on a 24/7 basis. Data Collection In the study, children treated in pediatric surgery and followed up with drainage system after abdominal surgery will be evaluated in terms of sampling criteria and children who do not meet the criteria will be excluded from the study.
Application
- Phase: The necessary ethics committee and institutional permission will be obtained before starting the study.
- Stage: The decision to remove the drainage system after the end of function or end of indication is communicated to the investigator by the physician.
- Stage: After obtaining written informed consent from the child\'s parents for the drain removal procedure, the researcher will explain the drain removal procedure and what will be done during the procedure to the parents. Then the descriptive information form will be filled.
- Stage: Physiological parameters (pulse, blood pressure, respiration, SPO2 ) of the children will be measured by the researcher before and after the procedure.
- Before the procedure, the necessary materials (ice pack or warm gel ice, infrared thermometer, gloves, saline, scalpel, clamp, sterile sponge, plaster and scissors) will be prepared and the drainage system will be clamped.
- The parent and nurse will assess and record the child pain score 15 minutes before, during and 15 minutes after the procedure. The child will be asked to make the same assessments and the results will be recorded.
Ice pack application group: An ice pack kept in the refrigerator and having a temperature of -10 degrees Celsius will be wrapped in sterile gauze and applied to the drain area of the pediatric patient who is decided to end the surgical drain indication. The temperature of the area where the ice pack is applied will be measured at one minute intervals, and when the relevant area reaches a temperature of 13.6 0C, the physician will be informed and the drain removal procedure will be initiated. The child will be asked to mark the degree of pain felt before, during and after the procedure.
Warm gel pad application group: Gel pads kept at room temperature will be applied to the drain area of the pediatric patient whose surgical drain indication is decided to end, in a sheath designed to wrap around the drain. After waiting for 10 minutes in the application area, the drainage system will be removed by the physician.
Control group: The integrated drainage system will be withdrawn by the physician. The child will not receive any non-pharmacologic intervention before, during or after the procedure.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ice pack | Experimental | Other: Ice packIce pack application group: An ice pack kept in the refrigerator and having a temperature of -10 degrees Celsius will be wrapped in sterile gauze and applied to the drain area of the pediatric patient who is decided to end the surgical drain indication. The temperature of the area where the ice pack is applied will be measured at one minute intervals, and when the relevant area reaches a temperature of 13.6 0C, the physician will be informed and the drain removal procedure will be initiated. The child will be asked to mark the degree of pain felt before, during and after the procedure. |
| warm gel | Experimental | Other: warm gel padWarm gel pad application group: Gel pads kept at room temperature will be applied to the drain area of the pediatric patient whose surgical drain indication is decided to end, in a sheath designed to wrap around the drain. After waiting for 10 minutes in the application area, the drainage system will be removed by the physician. |
| Control | No intervention | –Control group: The integrated drainage system will be withdrawn by the physician. The child will not receive any non-pharmacologic intervention before, during or after the procedure. |
Who may qualify
- Ages
- 9 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- The child must be between the ages of 9 and 18,
- The child does not have developmental delay (Developmental Problems: Delay in one or more of the developmental areas such as communication, social-emotional, cognitive, sensory functions, fine-rough movements, self-care, loss of function, loss of ability, loss of ability, limitation of participation in life as a result of disease)
- Follow-up with surgical drain
- The child does not have a chronic disease that may affect his/her life
- Voluntariness of the parent and child to participate in the study
Key exclusion criteria (7 listed)
- The child is under 9 years of age
- Communication problems
- Not volunteering to participate in the study
- Presence of more than one surgical drain
- The presence of developmental delay in the child (Developmental Problems: Delay in one or more of the developmental areas such as communication, social-emotional, cognitive, sensory functions, fine-rude movements, self-care, loss of function, loss of ability, loss of ability, restriction of participation in life as a result of disease)
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 |
|---|---|---|
| Ice packThe temperature of the area where the ice pack is applied will be measured at one minute intervals, and when the relevant area reaches a temperature of 13.6 0C, the physician will be informed and the drain removal procedure will be initiated. | Other | Ice pack |
| warm gel padGel pads kept at room temperature will be applied to the drain area of the pediatric patient whose surgical drain indication is decided to end, in a sheath designed to wrap around the drain. After waiting for 10 minutes in the application area, the drainage system will be removed by the physician. | Other | warm gel |
Primary outcome
State-Trait Continuity Inventory for Children
Time frame: 1 hour
State-Trait Continuity Inventory for Children : The inventory, which is used to measure the state and trait anxiety states of children, was developed by Spielberger in 1973. It is a simplified form of the State-Trait Anxiety Inventory developed for adults for children. While the number of options was 4 in the adult form, it was reduced to 3 in the child form. Özusta translated the inventory into Turkish and conducted an application study.
Pain level
Time frame: 1 hour
Numerical Pain Scale : This method, which aims to determine the severity of pain, aims to explain the patient\'s pain in numbers. On numerical scales, absence of pain (0) is evaluated as unbearable pain (10).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Results publication: PubMed 37664777Simsek Yaban Z, Alvarez-Garcia C, Bozdemir H. The effect of cold application on pain during the chest tube removal: A meta-analysis. Turk Gogus Kalp Damar Cerrahisi Derg. 2023 Jul 27;31(3):398-407. doi: 10.5606/tgkdc.dergisi.2023.23846. eCollection 2023 Jul.
- Results publicationKazan AGDEE. (2011). Soğuk Uygulamalar ve Hemşirelik Bakımı. HUHEMFAD. 18(1):73-82.
- Results publication: PubMed 26287712Knowlton MC. Nurse's guide to surgical drain removal. Nursing. 2015 Sep;45(9):59-61. doi: 10.1097/01.NURSE.0000470418.02063.ca. No abstract available.
- Results publicationÖzveren, H. (2011). Ağrı kontrolünde farmakolojik olmayan yöntemler. Sağlık Bilimleri Fakültesi Hemşirelik Dergisi, 18(1), 83-92.
- Results publication: PubMed 22082021Ertug N, Ulker S. The effect of cold application on pain due to chest tube removal. J Clin Nurs. 2012 Mar;21(5-6):784-90. doi: 10.1111/j.1365-2702.2011.03955.x. Epub 2011 Nov 15.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Ice pack and warm gel pad in people with Pain and Anxiety, run by Tarsus University.
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 7 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: status not confirmed, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Atiye Karakul, Phd (+903246000033, atiyekarakul@tarsus.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State-Trait Continuity Inventory for Children (time frame: 1 hour). The study lists 2 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 NCT06600763, which also lists 5 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 23 Sep 2024.