HeadacheNCT04707586
Lokal Cold Application in Nitroglycerin-Induced Headache (NIH)
A study testing Cold Application in people with Headache, run by Yasemin Kalkan Uğurlu at 2 sites in Turkey (Türkiye).
Trial summary
The study was planned to evaluate the effect of local cold application on headache severity in individuals who received intravenous nitroglycerin treatment, which mostly causes headache due to its vasoditator effect. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Headache
- What is being tested?
- Cold Application
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Dec 2020to 15 Mar 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The patient's volunteerism to participate in the research,
- Over the age of 18,
- Being conscious,
- Any analgesic, NSAID, triptan etc. Not taking antimigren drugs or opioids,
- No cold allergies.
Who cannot join
- Difficulty in communicating (speaking, perception, language, comprehension problems),
- Vision and / or hearing loss,
- Having a cold allergy.
- Blood pressure above 150/90 mm / Hg.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Nuray Enc
Istanbul
Nuray Enc, Prof. Dr., +90 5337261618, nurayenc@gmail.com
- Recruiting
Yasemin Kalkan Uğurlu
Ordu, 52200
Yasemin K Uğurlu, 05465674652, yasemin_kalkan24@hotmail.com
About this study
Official title: The Effect of Lokal Cold Application in Nitroglycerin-Induced Headache
The study was planned to evaluate the effect of local cold application on headache severity in individuals who received intravenous nitroglycerin treatment, which mostly causes headache due to its vasoditator effect. It is thought that the results to be obtained may provide evidence for the development of patient care guidelines.
Read the detailed description
The study was planned to evaluate the effect of local cold application on headache severity in individuals who received intravenous nitroglycerin treatment, which mostly causes headache due to its vasoditator effect.
Inclusion criteria;
- The patient's volunteerism to participate in the research,
- Over the age of 18,
- Being conscious,
- Any analgesic, NSAID, triptan etc. Not taking antimigren drugs or opioids,
- No cold allergies. Exclusion Criteria;
- Difficulty in communicating (speaking, perception, language, comprehension problems),
- Vision and / or hearing loss,
- Having a cold allergy.
Purpose and Type of Research:
This research was planned as a quasi-experimental, two-group, pretest-posttest study to determine the effect of local cold application on headache in individuals treated with intravenous NTG, which mostly causes headache due to its vasodilator effect.
Place and Time of the Study It will be carried out in Ordu State Hospital Coronary Intensive Care Unit between 15 December 2020 - 15 December November 2021.
Research Population and Sample The universe of the study is planned to be composed of all patients who were hospitalized in Ordu State Hospital Coronary Intensive Care Unit between December 2020 and December 2021 and received intravenous nitroglycerine treatment.
The sample of the study will be the patients who meet the sample selection criteria and are willing to participate in the study. The research sample will consist of experimental and control groups.
Experiment 1:Local cold application was applied to the patients with the help of the applicator during the first 20 minutes of the nitroglycerin infusion. The patient was followed up during the cold application, after the procedure, the patient was evaluated in detail using the Patient Follow-up Form and VAS, and his questions were answered. The patient was given detailed information about the application before the procedure.
Experiment 2: The patients were evaluated in detail using the Patient Follow-up Form and VAS for the first 12 hours of the infusion. Local cold application was applied for 20 minutes with the help of the applicator to the patients who developed headache. Immediately after the cold application, it was evaluated in detail using the Patient Follow-up Form and VAS. The groups were compared according to the data obtained.
Power analysis (G*Power 3.1.9.2) was performed to determine the sample size of the study. As a result of the analysis; In the evaluation made according to headache severity, the sample size determined for Power:0.80, β:0.20 and α:0.05 is a minimum of 14 patients for each group. However, to increase the reliability of the study and considering that there may be patients who could leave the study during the study, the total number of samples was determined as 70, 35 in the experimental 1 group and 35 in the experimental 2 group.
Data Collection Method
- Individuals who meet the criteria for inclusion in the sampling will be informed about the purpose, content and method of the research, and after the randomization process, experimental and control groups will be formed by obtaining the necessary written permission from those who agree to participate in the study.
- The research will consist of 2 groups as Experiment 1(Group of Local Cold Application at the Beginning of Infusion) and Experiment 2 (The Group Not Applying Local Cold at the Beginning of Infusion)
- Data will be collected by the researcher.
- Within the scope of the research, the patients in the experimental group who used the cold application bandage will be informed about the use of the bandage.
- Patient Information Form, Patient Follow-up Form and Visual Pain Perception Scale will be used to evaluate the sociodemographic, disease, treatment and pain level of all patients participating in the study prior to nitroglycerin infusion.
- A cold application bandage will be attached to the experimental 1 group and local cold application will be applied to the patient for the first 20 minutes of the nitroglycerine infusion. After 20 minutes, the bandage will be removed from the patient and the cold application will be terminated. The patient will be followed during the cold application, and the questions of the patient will be answered after the procedure. Immediately after the cold application, the patient's headache will be evaluated in detail using the Visual Pain Perception Scale and the Patient Follow-up Form.
- Patients in the experimental 2 group who develop headaches will be evaluated in detail using the Visual Pain Perception Scale and the Patient Follow-up Form, a cold application bandage will be worn and local cold application will be performed for 20 minutes. Immediately after the cold application, it will be evaluated in detail again using the Visual Pain Perception Scale and Patient Monitoring Form. In this way, the preventive and therapeutic effect of local cold application will be evaluated in patients receiving intravenous nitroglycerin treatment.
- Groups will be compared according to the data obtained.
- Conditions
- Headache
- Being tested
- Cold Application
- Keywords
- Cryotherapy, Headache, Nitrates,
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold ApplicationOther
Created by the researcher; A bandage with 3 pieces of 13x10 cm cold gel and a cold gel container in which they are placed will be used, which can be adjusted according to the head circumference of the patient between 60-80 cm in length. The ability of the cold gel cups of the bandage to be moved on the bandage will allow comfortable cold application to the patient's bilateral frontotemporal and occipital areas at the same time. After waiting for 20 minutes in the freezer part of the refrigerator, the temperature and temperature of the gels applied and the cold application area before and after each application will be measured and recorded. An Infrared Non-Contact Food Thermometer will be used for temperature measurement of cold gel packs, and an Infrared Non-Contact Thermometer device will be used for temperature measurement of the cold application area.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No application will be made to patients in this group. Routine patient care will be provided. After the patients who develop pain are recorded, the application will be made with a cold application bandage. |
| experimental group | Experimental | Patients in this group will be applied cold application with cold application bandage for 20 minutes as soon as the infusion begins. Receives: Other: Cold Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." The distance between 'no pain' and the mark then defines the subject's pain.
Measured: 30 minutes, 3.,6., 9. and 12. hours after nitroglycerin infusion starts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start15 Dec 2020
- Primary completion15 Jan 2022 (estimated)
- Study completion15 Mar 2022 (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 HeadacheStudies 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
- The quasi-experimental, two-group, pretest-posttest study
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yasemin Kalkan Uğurlu
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Responsible party
- Sponsor-investigator, Yasemin Kalkan Uğurlu, Ordu University
- Investigators
- Yasemin K Uğurlu, Principal investigator, Ordu Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04707586
- Sponsor's protocol ID
- 9080
- Other IDs
- 7bRd8d6b
- Status last verified
- Sep 2021
- First submitted
- 23 Dec 2020
- Last updated
- 10 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol will be shared after the study is finished.
Publications
Sprouse-Blum AS, Gabriel AK, Brown JP, Yee MH. Randomized controlled trial: targeted neck cooling in the treatment of the migraine patient. Hawaii J Med Public Health. 2013 Jul;72(7):237-41.
PubMed 23901394Demir Y, Khorshid L. The effect of cold application in combination with standard analgesic administration on pain and anxiety during chest tube removal: a single-blinded, randomized, double-controlled study. Pain Manag Nurs. 2010 Sep;11(3):186-96. doi: 10.1016/j.pmn.2009.09.002. Epub 2010 May 31.
PubMed 20728068Ertug 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 22082021Fraser F, Matsuzawa Y, Lee YSC, Minen M. Behavioral Treatments for Post-Traumatic Headache. Curr Pain Headache Rep. 2017 May;21(5):22. doi: 10.1007/s11916-017-0624-x.
PubMed 28283812Ucler S, Coskun O, Inan LE, Kanatli Y. Cold Therapy in Migraine Patients: Open-label, Non-controlled, Pilot Study. Evid Based Complement Alternat Med. 2006 Dec;3(4):489-93. doi: 10.1093/ecam/nel035. Epub 2006 Jun 15.
PubMed 17173113
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lokal Cold Application in Nitroglycerin-Induced Headache
- ClinicalTrials.gov ID
- NCT04707586
- Acronym / sponsor ID
- 9080
- Conditions
- Headache
- Keywords
- Cryotherapy, Headache, Nitrates,
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Yasemin Kalkan UğurluUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 15 Jan 2022 (estimated)
- Study completion
- 15 Mar 2022 (estimated)
- First posted
- 13 Jan 2021 (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 to evaluate the effect of local cold application on headache severity in individuals who received intravenous nitroglycerin treatment, which mostly causes headache due to its vasoditator effect. It is thought that the results to be obtained may provide evidence for the development of patient care guidelines.
Detailed description
The study was planned to evaluate the effect of local cold application on headache severity in individuals who received intravenous nitroglycerin treatment, which mostly causes headache due to its vasoditator effect.
Inclusion criteria;
- The patient's volunteerism to participate in the research,
- Over the age of 18,
- Being conscious,
- Any analgesic, NSAID, triptan etc. Not taking antimigren drugs or opioids,
- No cold allergies. Exclusion Criteria;
- Difficulty in communicating (speaking, perception, language, comprehension problems),
- Vision and / or hearing loss,
- Having a cold allergy.
Purpose and Type of Research:
This research was planned as a quasi-experimental, two-group, pretest-posttest study to determine the effect of local cold application on headache in individuals treated with intravenous NTG, which mostly causes headache due to its vasodilator effect.
Place and Time of the Study It will be carried out in Ordu State Hospital Coronary Intensive Care Unit between 15 December 2020 - 15 December November 2021.
Research Population and Sample The universe of the study is planned to be composed of all patients who were hospitalized in Ordu State Hospital Coronary Intensive Care Unit between December 2020 and December 2021 and received intravenous nitroglycerine treatment.
The sample of the study will be the patients who meet the sample selection criteria and are willing to participate in the study. The research sample will consist of experimental and control groups.
Experiment 1:Local cold application was applied to the patients with the help of the applicator during the first 20 minutes of the nitroglycerin infusion. The patient was followed up during the cold application, after the procedure, the patient was evaluated in detail using the Patient Follow-up Form and VAS, and his questions were answered. The patient was given detailed information about the application before the procedure.
Experiment 2: The patients were evaluated in detail using the Patient Follow-up Form and VAS for the first 12 hours of the infusion. Local cold application was applied for 20 minutes with the help of the applicator to the patients who developed headache. Immediately after the cold application, it was evaluated in detail using the Patient Follow-up Form and VAS. The groups were compared according to the data obtained.
Power analysis (G*Power 3.1.9.2) was performed to determine the sample size of the study. As a result of the analysis; In the evaluation made according to headache severity, the sample size determined for Power:0.80, β:0.20 and α:0.05 is a minimum of 14 patients for each group. However, to increase the reliability of the study and considering that there may be patients who could leave the study during the study, the total number of samples was determined as 70, 35 in the experimental 1 group and 35 in the experimental 2 group.
Data Collection Method
- Individuals who meet the criteria for inclusion in the sampling will be informed about the purpose, content and method of the research, and after the randomization process, experimental and control groups will be formed by obtaining the necessary written permission from those who agree to participate in the study.
- The research will consist of 2 groups as Experiment 1(Group of Local Cold Application at the Beginning of Infusion) and Experiment 2 (The Group Not Applying Local Cold at the Beginning of Infusion)
- Data will be collected by the researcher.
- Within the scope of the research, the patients in the experimental group who used the cold application bandage will be informed about the use of the bandage.
- Patient Information Form, Patient Follow-up Form and Visual Pain Perception Scale will be used to evaluate the sociodemographic, disease, treatment and pain level of all patients participating in the study prior to nitroglycerin infusion.
- A cold application bandage will be attached to the experimental 1 group and local cold application will be applied to the patient for the first 20 minutes of the nitroglycerine infusion. After 20 minutes, the bandage will be removed from the patient and the cold application will be terminated. The patient will be followed during the cold application, and the questions of the patient will be answered after the procedure. Immediately after the cold application, the patient's headache will be evaluated in detail using the Visual Pain Perception Scale and the Patient Follow-up Form.
- Patients in the experimental 2 group who develop headaches will be evaluated in detail using the Visual Pain Perception Scale and the Patient Follow-up Form, a cold application bandage will be worn and local cold application will be performed for 20 minutes. Immediately after the cold application, it will be evaluated in detail again using the Visual Pain Perception Scale and Patient Monitoring Form. In this way, the preventive and therapeutic effect of local cold application will be evaluated in patients receiving intravenous nitroglycerin treatment.
- Groups will be compared according to the data obtained.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- The quasi-experimental, two-group, pretest-posttest study
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No application will be made to patients in this group. Routine patient care will be provided. After the patients who develop pain are recorded, the application will be made with a cold application bandage. |
| experimental group | Experimental | Other: Cold ApplicationPatients in this group will be applied cold application with cold application bandage for 20 minutes as soon as the infusion begins. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patient's volunteerism to participate in the research,
- Over the age of 18,
- Being conscious,
- Any analgesic, NSAID, triptan etc. Not taking antimigren drugs or opioids,
- No cold allergies.
Key exclusion criteria (4 listed)
- Difficulty in communicating (speaking, perception, language, comprehension problems),
- Vision and / or hearing loss,
- Having a cold allergy.
- Blood pressure above 150/90 mm / Hg.
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 |
|---|---|---|
| Cold ApplicationCreated by the researcher; A bandage with 3 pieces of 13x10 cm cold gel and a cold gel container in which they are placed will be used, which can be adjusted according to the head circumference of the patient between 60-80 cm in length. The ability of the cold gel cups of the bandage to be moved on the bandage will allow comfortable cold application to the patient's bilateral frontotemporal and occipital areas at the same time. After waiting for 20 minutes in the freezer part of the refrigerator, the temperature and temperature of the gels applied and the cold application area before and after each application will be measured and recorded. An Infrared Non-Contact Food Thermometer will be used for temperature measurement of cold gel packs, and an Infrared Non-Contact Thermometer device will be used for temperature measurement of the cold application area. | Other | experimental group |
Primary outcome
Headache
Time frame: 30 minutes, 3.,6., 9. and 12. hours after nitroglycerin infusion starts
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." The distance between 'no pain' and the mark then defines the subject's pain.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2021.
- Background: PubMed 23901394Sprouse-Blum AS, Gabriel AK, Brown JP, Yee MH. Randomized controlled trial: targeted neck cooling in the treatment of the migraine patient. Hawaii J Med Public Health. 2013 Jul;72(7):237-41.
- Background: PubMed 20728068Demir Y, Khorshid L. The effect of cold application in combination with standard analgesic administration on pain and anxiety during chest tube removal: a single-blinded, randomized, double-controlled study. Pain Manag Nurs. 2010 Sep;11(3):186-96. doi: 10.1016/j.pmn.2009.09.002. Epub 2010 May 31.
- Background: 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.
- Results publication: PubMed 28283812Fraser F, Matsuzawa Y, Lee YSC, Minen M. Behavioral Treatments for Post-Traumatic Headache. Curr Pain Headache Rep. 2017 May;21(5):22. doi: 10.1007/s11916-017-0624-x.
- Results publication: PubMed 17173113Ucler S, Coskun O, Inan LE, Kanatli Y. Cold Therapy in Migraine Patients: Open-label, Non-controlled, Pilot Study. Evid Based Complement Alternat Med. 2006 Dec;3(4):489-93. doi: 10.1093/ecam/nel035. Epub 2006 Jun 15.
- Individual participant dataSharing planned: Yes. The study protocol will be shared after the study is finished.
Related trials for Headache
Recruiting
Dietary Intervention for Migraine Relief
Migraine
Active, not recruiting
Acceptance and Commitment Therapy-Based Group Psychotherapy for Chronic Headache
Chronic Headache
Active, not recruiting
The Role Of Fascia And Breathing Exercises In The Treatment Of Cervicogenic Headache
Cervicogenic Headache
Active, not recruitingObservational study
Efficacy of Rimegepant 75 mg for the Acute Treatment of Migraine: a Bayesian Individual Participant Data Meta-analysis Standardized to Defined Target Populations
Migraine
Active, not recruitingObservational study
Study of Pregnancy Outcomes in Women Exposed to Rimegepant During Pregnancy
Migraine
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.
Yasemin K Uğurlu principal investigator
Ordu Üniversitesi
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold Application in people with Headache, run by Yasemin Kalkan Uğurlu at 2 sites 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 4 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 10 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yasemin K Uğurlu, MSCN (05465674652, yasemin_kalkan24@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache (time frame: 30 minutes, 3.,6., 9. and 12. hours after nitroglycerin infusion starts). 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 NCT04707586, 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 10 Sep 2021.