ThyroidectomyNCT05681338
Effect of the Coughing Technique During Subcutaneous Heparin Injection
A study testing the medium intensity coughing technique in people with Thyroidectomy and Colon Surgery, run by Uludag University at 1 site in Turkey (Türkiye).
Trial summary
Objective: to examine the effect of the medium intensity coughing technique during subcutaneous low molecular weight heparin injection on pain severity and individual satisfaction in general surgery patients. Read more about this study
- Who is it for?
- Ages 22 to 86 years
- Conditions the study is for
- Thyroidectomy, Colon Surgery, Cholecystectomy
- What is being tested?
- the medium intensity coughing technique
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Mar 2022to 30 Jun 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 22 to 86 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participating voluntarily in the study
- Being over the age of 18,
- Having a doctor's prescription for subcutaneous low molecular weight heparin 0.6 mL treatment and not yet having begun treatment.
- Having no coagulation disorder, having no disorder that could affect pain perception, -
- Having no incision, lipodystrophy, or finding of infection at the injection site,
- Having no communication problem
Who cannot join
- Not wanting to participate in the study, or during the course of the research, wishing to withdraw from the study
- Having any condition which would affect the sensation of pain
- Not being able to agree on a place or time
- Being less than 18 years of age
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bursa Uludag University Hospital
Bursa, Nilüfer, 16059
About this study
Official title: Effect of the Coughing Technique During Subcutaneous Heparin Injection on Pain Severity and Individual Satisfaction
Objective: to examine the effect of the medium intensity coughing technique during subcutaneous low molecular weight heparin injection on pain severity and individual satisfaction in general surgery patients. Method: a prospective, quasi-experimental study included 100 patients who had prescribed a subcutaneous low molecular weight heparin injection once in 24 hours. Each patient received two injections by the same researcher using standard injection technique with medium intensity coughing technique and only standard injection technique.
Read the detailed description
Aims and objectives: The aim of this study was to examine the effect on the level of pain severity and satisfaction of patients of the medium intensity coughing technique applied to patients during the administration of subcutaneous low molecular weight heparin (LMWH) injection.
Design: This research was a prospective quasi-experimental study. Methods: It was conducted with 100 patients in the General Surgery Clinic of a university hospital in the Marmara Region of Turkey. Subcutaneous LMWH injections were administered by the same nurse to the outer side of the right and left upper arms by the standard injection technique and the medium intensity coughing technique. Immediately after the subcutaneous LMWH injection was given, a researcher who did not know which injection method had been used asked the patients to evaluate their pain levels by the Visual Analog Scale (VAS) and their satisfaction with the performance of the injection by the Visual Individual Satisfaction Scale (VISS).
- Conditions
- Thyroidectomy, Colon Surgery, Cholecystectomy, Inguinal Hernia
- Being tested
- the medium intensity coughing technique
- Keywords
- subcutaneous heparin injection, coughing technique, pain, individual satisfaction, non-pharmacological method
- Medical subject headings
- Hernia, Inguinal, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the medium intensity coughing techniqueOther
The medium intensity coughing technique: Immediately before the subcutaneous LMWH injection was given, patients were asked to cough twice at a medium level. After that, they were asked to cough ten seconds later for a second time at the same level, and while they were coughing for the second time, the needle was inserted into the tissue.
| Study group | Role | What they receive |
|---|---|---|
| the medium intensity coughing technique | Experimental | Immediately before the subcutaneous heparin injection was given, patients were asked to cough twice at a medium level. After that, they were asked to cough ten seconds later for a second time at the same level, and while they were coughing for the second time, the needle was inserted into the tissue. Receives: Other: the medium intensity coughing technique |
| the standard injection technique | No intervention | During the subcutaneous heparin injection, patients were not asked to perform any action, and the injection was given by the standard technique. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessed by Visual Analog Scale (VAS)
In evaluating the severity of pain felt by the patients during subcutaneous injections, a 10 cm long vertical VAS was used, on which one end represented no pain, and the other end the worst possible pain. The VAS is a commonly used pain assessment scale in clinical settings. Pain severity measurements were evaluated in millimeters.
Measured: 2 months
"Satisfaction assessed by the Visual Individual Satisfaction Scale (VISS)
During the administration of the injection, an evaluation was made to determine individuals' satisfaction using the Visual Individual Satisfaction Scale, which consisted of a vertical 10 cm scale with "I'm very satisfied" written at one end of it and "I'm not at all satisfied" at the other. The Visual Individual Satisfaction Scale incorporated the characteristics of the well-known Visual Analog Scale (VAS). Satisfaction level measurements were evaluated in millimeters.
Measured: 2 months
Secondary outcomes (3)
Weight
weight in kilograms
Measured: 2 months
Height
height in meters
Measured: 2 months
BMI
BMI in kg/m^2
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start17 Mar 2022
- Primary completion30 May 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ThyroidectomyStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Yilmaz, PhD, Uludag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05681338
- Sponsor's protocol ID
- 2022-6/18
- Status last verified
- Mar 2025
- First submitted
- 25 Dec 2022
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yilmaz D, Ayhan D, Yilmaz DU, Duzgun F. Effect of the coughing technique during subcutaneous heparin injection on pain severity and individual satisfaction. Rev Lat Am Enfermagem. 2023 May 15;31:e3923. doi: 10.1590/1518-8345.6504.3923. eCollection 2023.
PubMed 37194813
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Coughing Technique During Subcutaneous Heparin Injection on Pain Severity and Individual Satisfaction
- ClinicalTrials.gov ID
- NCT05681338
- Acronym / sponsor ID
- 2022-6/18
- Conditions
- Thyroidectomy, Colon Surgery, Cholecystectomy, Inguinal Hernia
- Keywords
- subcutaneous heparin injection, coughing technique, pain, individual satisfaction, non-pharmacological method
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- 17 Mar 2022 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 12 Jan 2023 (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.
Objective: to examine the effect of the medium intensity coughing technique during subcutaneous low molecular weight heparin injection on pain severity and individual satisfaction in general surgery patients. Method: a prospective, quasi-experimental study included 100 patients who had prescribed a subcutaneous low molecular weight heparin injection once in 24 hours. Each patient received two injections by the same researcher using standard injection technique with medium intensity coughing technique and only standard injection technique.
Detailed description
Aims and objectives: The aim of this study was to examine the effect on the level of pain severity and satisfaction of patients of the medium intensity coughing technique applied to patients during the administration of subcutaneous low molecular weight heparin (LMWH) injection.
Design: This research was a prospective quasi-experimental study. Methods: It was conducted with 100 patients in the General Surgery Clinic of a university hospital in the Marmara Region of Turkey. Subcutaneous LMWH injections were administered by the same nurse to the outer side of the right and left upper arms by the standard injection technique and the medium intensity coughing technique. Immediately after the subcutaneous LMWH injection was given, a researcher who did not know which injection method had been used asked the patients to evaluate their pain levels by the Visual Analog Scale (VAS) and their satisfaction with the performance of the injection by the Visual Individual Satisfaction Scale (VISS).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the medium intensity coughing technique | Experimental | Other: the medium intensity coughing techniqueImmediately before the subcutaneous heparin injection was given, patients were asked to cough twice at a medium level. After that, they were asked to cough ten seconds later for a second time at the same level, and while they were coughing for the second time, the needle was inserted into the tissue. |
| the standard injection technique | No intervention | –During the subcutaneous heparin injection, patients were not asked to perform any action, and the injection was given by the standard technique. |
Who may qualify
- Ages
- 22 to 86 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participating voluntarily in the study
- Being over the age of 18,
- Having a doctor's prescription for subcutaneous low molecular weight heparin 0.6 mL treatment and not yet having begun treatment.
- Having no coagulation disorder, having no disorder that could affect pain perception, -
- Having no incision, lipodystrophy, or finding of infection at the injection site,
Key exclusion criteria (4 listed)
- Not wanting to participate in the study, or during the course of the research, wishing to withdraw from the study
- Having any condition which would affect the sensation of pain
- Not being able to agree on a place or time
- Being less than 18 years of age
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 |
|---|---|---|
| the medium intensity coughing techniqueThe medium intensity coughing technique: Immediately before the subcutaneous LMWH injection was given, patients were asked to cough twice at a medium level. After that, they were asked to cough ten seconds later for a second time at the same level, and while they were coughing for the second time, the needle was inserted into the tissue. | Other | the medium intensity coughing technique |
Primary outcome
Pain assessed by Visual Analog Scale (VAS)
Time frame: 2 months
In evaluating the severity of pain felt by the patients during subcutaneous injections, a 10 cm long vertical VAS was used, on which one end represented no pain, and the other end the worst possible pain. The VAS is a commonly used pain assessment scale in clinical settings. Pain severity measurements were evaluated in millimeters.
"Satisfaction assessed by the Visual Individual Satisfaction Scale (VISS)
Time frame: 2 months
During the administration of the injection, an evaluation was made to determine individuals' satisfaction using the Visual Individual Satisfaction Scale, which consisted of a vertical 10 cm scale with "I'm very satisfied" written at one end of it and "I'm not at all satisfied" at the other. The Visual Individual Satisfaction Scale incorporated the characteristics of the well-known Visual Analog Scale (VAS). Satisfaction level measurements were evaluated in millimeters.
3 secondary outcomes
Weight
Time frame: 2 months
Height
Time frame: 2 months
BMI
Time frame: 2 months
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 6 Mar 2025.
- Derived from this study: PubMed 37194813Yilmaz D, Ayhan D, Yilmaz DU, Duzgun F. Effect of the coughing technique during subcutaneous heparin injection on pain severity and individual satisfaction. Rev Lat Am Enfermagem. 2023 May 15;31:e3923. doi: 10.1590/1518-8345.6504.3923. eCollection 2023.
- 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.
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 the medium intensity coughing technique in people with Thyroidectomy and Colon Surgery, run by Uludag 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 6 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: finished, as of the sponsor's last update on 6 Mar 2025. 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 assessed by Visual Analog Scale (VAS) (time frame: 2 months). 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 NCT05681338, which also lists 1 linked publication.
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 6 Mar 2025.