Pain, PostoperativeNCT05875337
The Effect of Acupressure on Procedural Pain, Anxiety and Hemodynamic Variables During Chest Tube Removal
A study testing Acupressure in people with Pain, Postoperative and Anxiety, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
When the literature was reviewed, many studies were found in which various non-pharmacologic interventions such as reflexology, music therapy, slow and deep breathing exercises, relaxation exercises and cold application were examined in the control of pain associated with chest tube removal. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Anxiety, Hemodynamic Instability
- What is being tested?
- Acupressure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 May 2023to 25 May 2024
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- With only one chest tube after open heart surgery,
- 18 years of age or older,
- Conscious and cooperative,
- Speaks and understands Turkish,
- General condition and hemodynamic variables are stable,
- Planned surgical intervention,
Show all 12Show fewer
- No previous chest tube experience,
- Acupressure/placebo acupressure without scars, scars, tenderness in the area to be acupressure,
- No active COVID-19 infection,
- Does not have any psychiatric diagnosis,
- Not using psychiatric and/or local neuromuscular blocking drugs,
- Patients who agreed to participate in the study (signed the Informed Consent Form)
Who cannot join
- No chest tube or multiple chest tubes after open heart surgery,
- Under 18 years of age,
- Conscious and uncooperative,
- Speaking Turkish but not understanding it,
- Unstable general condition and hemodynamic variables,
- Underwent emergency surgical intervention,
Show all 12Show fewer
- Anyone with previous chest tube experience,
- Wounds, scars, tenderness in the area where acupressure/placebo acupressure will be applied,
- With active COVID-19 infection,
- Has an existing psychiatric diagnosis,
- Psychiatric and/or local neuromuscular blocking drugs,
- Patients who did not agree to participate in the study (did not sign the Informed Consent Form).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mersin University Hospital
Mersin, Yenişehir, 33343
About this study
Official title: The Effect of Acupressure on Procedural Pain, Anxiety and Hemodynamic Variables During Chest Tube Removal in Patients With Open Heart Surgery: A Double-Blind Randomized Controlled Trial
When the literature was reviewed, many studies were found in which various non-pharmacologic interventions such as reflexology, music therapy, slow and deep breathing exercises, relaxation exercises and cold application were examined in the control of pain associated with chest tube removal. However, a limited number of studies have examined the effect of acupressure on the control of pain caused by chest tube removal; there are no studies in which LI4, LI11 and HT7 acupressure points were used and anxiety level and hemodynamic variables were examined along with procedural pain. Thus, the aim of this study was to investigate the effect of acupressure on procedural pain, anxiety and hemodynamic variables after chest tube removal after open heart surgery.
Read the detailed description
Before starting the acupressure/placebo acupressure point application, the area around the area where pressure will be applied for 20-30 seconds will be gently rubbed with the palm of the hand. By gently rubbing the surrounding tissue, tension and tissue sensitivity will be reduced and the tissue will be relaxed by heating, relaxing and preparing the point area. Pressure will be applied to the determined points (LI4, LI11 and HT7 or points 1.5 cm away) with the thumb, index or middle finger manually for 5 seconds to create a depth of 1-1.5 cm, and rest for 2 seconds. Each point will be applied for 2 minutes and the application will last 12 minutes.
When acupressure/plesebo acupressure application is completed, the chest tube will be removed by the physician. Procedural pain level, anxiety level and hemodynamic variables of all patients in the acupressure and placebo acupressure groups will be re-evaluated immediately and 15 minutes after removal of the chest tube.
- Conditions
- Pain, Postoperative, Anxiety, Hemodynamic Instability
- Being tested
- Acupressure, Placebo acupressure
- Medical subject headings
- Pain, Postoperative, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupressureOther
Before starting the acupressure point application, the area around the area where the pressure will be applied for 20-30 seconds will be gently rubbed with the palm of the hand. By gently rubbing the surrounding tissue, tension and tissue sensitivity will be reduced and the tissue will be relaxed by heating, relaxing and preparing the point area. Pressure will be applied to the determined points (LI4, LI11 and HT7) with the thumb, index or middle finger manually for 5 seconds to create a depth of 1-1.5 cm and rest for 2 seconds. Each point will be applied for 2 minutes and the application will last 12 minutes.
Placebo acupressureOther
Before starting the application to the placebo acupressure point, the area around the area where pressure will be applied for 20-30 seconds will be gently rubbed with the palm of the hand. By gently rubbing the surrounding tissue, tension and tissue sensitivity will be reduced and the tissue will be relaxed by heating, relaxing and preparing the point area. Light pressure will be applied to the determined points (1.5 cm away from LI4, LI11 and HT7 points) with the thumb, index or middle finger. Each point will be applied for 2 minutes and the application will last 12 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Acupressure Group (experimental) | Experimental | In the acupressure groups the points are LI4, LI11 and HT7. Receives: Other: Acupressure |
| Placebo Acupressure Group (control) | Placebo comparator | In the placebo acupressure group the points are 1.5 cm away from LI4, LI11 and HT7 points. Receives: Other: Placebo acupressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Pain on the Visual Analog Scale at 15 minutes
The VAS, which is a safe, easily applicable scale tool generally accepted in the literature, consists of a 10 cm long line and subjective descriptive statements at both ends of the scale (0 cm=none and 10 cm=highest degree of presence). The individual marks the appropriate place on the scale on this 10 cm line. The distance from the beginning of the scale to the mark is measured with a ruler and the pain level of the individual is determined numerically in cm.
Measured: Baseline and 15 minutes
Secondary outcomes (6)
Change from baseline in Anxiety on the State Anxiety Inventory at 15 minutes
The total score of the scale is calculated by subtracting the total weighted score of the inverted statements from the total weighted score of the direct statements and adding the number 50, which is the predetermined and unchanging value of the State Anxiety Inventory. A score of 30 and above on this scale indicates moderate anxiety and a score of 45 and above indicates severe anxiety.
Measured: Baseline and 15 minutes
Change from baseline in SpO2 at 15 minutes.
Oxygen saturation measured at the specified times will be recorded for the acupressure and placebo acupressure group patients. Hemodynamic variables will be monitored and recorded with a bedside monitor (Nihon Kohden, Tokyo). To ensure data reliability and accuracy, these monitors are calibrated monthly by the biomedical engineering department as per hospital policy.
Measured: Baseline and 15 minutes.
Change from in respiration rate at 15 minutes.
Respiration rate measured at the specified times will be recorded for the acupressure and placebo acupressure group patients. Hemodynamic variables will be monitored and recorded with a bedside monitor (Nihon Kohden, Tokyo). To ensure data reliability and accuracy, these monitors are calibrated monthly by the biomedical engineering department as per hospital policy.
Measured: Baseline and 15 minutes
Change from in systolic blood pressure at 15 minutes
Systolic blood pressure measured at the specified times will be recorded for the acupressure and placebo acupressure group patients. Hemodynamic variables will be monitored and recorded with a bedside monitor (Nihon Kohden, Tokyo). To ensure data reliability and accuracy, these monitors are calibrated monthly by the biomedical engineering department as per hospital policy.
Measured: Baseline and 15 minutes
Change from in diastolic blood pressure at 15 minutes.
Diastolic blood pressure measured at the specified times will be recorded for the acupressure and placebo acupressure group patients. Hemodynamic variables will be monitored and recorded with a bedside monitor (Nihon Kohden, Tokyo). To ensure data reliability and accuracy, these monitors are calibrated monthly by the biomedical engineering department as per hospital policy.
Measured: Baseline and 15 minutes
Change from in heart rate at 15 minutes.
Heart rate measured at the specified times will be recorded for the acupressure and placebo acupressure group patients. Hemodynamic variables will be monitored and recorded with a bedside monitor (Nihon Kohden, Tokyo). To ensure data reliability and accuracy, these monitors are calibrated monthly by the biomedical engineering department as per hospital policy.
Measured: Baseline and 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start25 May 2023
- Primary completion25 May 2023
- Study completion25 May 2024
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 Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Mersin UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind randomized controlled experimental trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tugba CAM YANIK, Mersin University
- Investigators
- Gülay ALTUN UĞRAŞ, PhD, Study director, Mersin UniversitySerpil YÜKSEL, PhD, Principal investigator, Necmettin Erbakan UniversityDidem KANDEMİR, PhD, Principal investigator, England
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05875337
- Sponsor's protocol ID
- MersinU.
- Status last verified
- Apr 2025
- First submitted
- 15 May 2023
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kandemir D, Yuksel S, Cam Yanik T, Ozdemir FE, Altun Ugras G. The Effect of Acupressure on Procedural Pain, Anxiety, and Hemodynamic Parameters During Chest Tube Removal in Open-Heart Surgery Patients: A Randomized Sham-Controlled Study. Pain Manag Nurs. 2026 May 26:S1524-9042(26)00146-3. doi: 10.1016/j.pmn.2026.04.010. Online ahead of print.
PubMed 42191514
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acupressure on Procedural Pain, Anxiety and Hemodynamic Variables During Chest Tube Removal in Patients With Open Heart Surgery: A Double-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05875337
- Acronym / sponsor ID
- MersinU.
- Conditions
- Pain, Postoperative, Anxiety, Hemodynamic Instability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 25 May 2023 (actual)
- Primary completion
- 25 May 2023 (actual)
- Study completion
- 25 May 2024 (actual)
- First posted
- 25 May 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.
When the literature was reviewed, many studies were found in which various non-pharmacologic interventions such as reflexology, music therapy, slow and deep breathing exercises, relaxation exercises and cold application were examined in the control of pain associated with chest tube removal. However, a limited number of studies have examined the effect of acupressure on the control of pain caused by chest tube removal; there are no studies in which LI4, LI11 and HT7 acupressure points were used and anxiety level and hemodynamic variables were examined along with procedural pain. Thus, the aim of this study was to investigate the effect of acupressure on procedural pain, anxiety and hemodynamic variables after chest tube removal after open heart surgery.
Detailed description
Before starting the acupressure/placebo acupressure point application, the area around the area where pressure will be applied for 20-30 seconds will be gently rubbed with the palm of the hand. By gently rubbing the surrounding tissue, tension and tissue sensitivity will be reduced and the tissue will be relaxed by heating, relaxing and preparing the point area. Pressure will be applied to the determined points (LI4, LI11 and HT7 or points 1.5 cm away) with the thumb, index or middle finger manually for 5 seconds to create a depth of 1-1.5 cm, and rest for 2 seconds. Each point will be applied for 2 minutes and the application will last 12 minutes.
When acupressure/plesebo acupressure application is completed, the chest tube will be removed by the physician. Procedural pain level, anxiety level and hemodynamic variables of all patients in the acupressure and placebo acupressure groups will be re-evaluated immediately and 15 minutes after removal of the chest tube.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind randomized controlled experimental trial
| Arm | Type | Receives |
|---|---|---|
| Acupressure Group (experimental) | Experimental | Other: AcupressureIn the acupressure groups the points are LI4, LI11 and HT7. |
| Placebo Acupressure Group (control) | Placebo comparator | Other: Placebo acupressureIn the placebo acupressure group the points are 1.5 cm away from LI4, LI11 and HT7 points. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- With only one chest tube after open heart surgery,
- 18 years of age or older,
- Conscious and cooperative,
- Speaks and understands Turkish,
- General condition and hemodynamic variables are stable,
Key exclusion criteria (12 listed)
- No chest tube or multiple chest tubes after open heart surgery,
- Under 18 years of age,
- Conscious and uncooperative,
- Speaking Turkish but not understanding it,
- Unstable general condition and hemodynamic variables,
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 |
|---|---|---|
| AcupressureBefore starting the acupressure point application, the area around the area where the pressure will be applied for 20-30 seconds will be gently rubbed with the palm of the hand. By gently rubbing the surrounding tissue, tension and tissue sensitivity will be reduced and the tissue will be relaxed by heating, relaxing and preparing the point area. Pressure will be applied to the determined points (LI4, LI11 and HT7) with the thumb, index or middle finger manually for 5 seconds to create a depth of 1-1.5 cm and rest for 2 seconds. Each point will be applied for 2 minutes and the application will last 12 minutes. | Other | Acupressure Group (experimental) |
| Placebo acupressureBefore starting the application to the placebo acupressure point, the area around the area where pressure will be applied for 20-30 seconds will be gently rubbed with the palm of the hand. By gently rubbing the surrounding tissue, tension and tissue sensitivity will be reduced and the tissue will be relaxed by heating, relaxing and preparing the point area. Light pressure will be applied to the determined points (1.5 cm away from LI4, LI11 and HT7 points) with the thumb, index or middle finger. Each point will be applied for 2 minutes and the application will last 12 minutes. | Other | Placebo Acupressure Group (control) |
Primary outcome
Change from baseline in Pain on the Visual Analog Scale at 15 minutes
Time frame: Baseline and 15 minutes
The VAS, which is a safe, easily applicable scale tool generally accepted in the literature, consists of a 10 cm long line and subjective descriptive statements at both ends of the scale (0 cm=none and 10 cm=highest degree of presence). The individual marks the appropriate place on the scale on this 10 cm line. The distance from the beginning of the scale to the mark is measured with a ruler and the pain level of the individual is determined numerically in cm.
6 secondary outcomes
Change from baseline in Anxiety on the State Anxiety Inventory at 15 minutes
Time frame: Baseline and 15 minutes
Change from baseline in SpO2 at 15 minutes.
Time frame: Baseline and 15 minutes.
Change from in respiration rate at 15 minutes.
Time frame: Baseline and 15 minutes
Change from in systolic blood pressure at 15 minutes
Time frame: Baseline and 15 minutes
Change from in diastolic blood pressure at 15 minutes.
Time frame: Baseline and 15 minutes
Change from in heart rate at 15 minutes.
Time frame: Baseline and 15 minutes
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 24 Apr 2025.
- Derived from this study: PubMed 42191514Kandemir D, Yuksel S, Cam Yanik T, Ozdemir FE, Altun Ugras G. The Effect of Acupressure on Procedural Pain, Anxiety, and Hemodynamic Parameters During Chest Tube Removal in Open-Heart Surgery Patients: A Randomized Sham-Controlled Study. Pain Manag Nurs. 2026 May 26:S1524-9042(26)00146-3. doi: 10.1016/j.pmn.2026.04.010. Online ahead of print.
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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.
Gülay ALTUN UĞRAŞ, PhD study director
Mersin University
Serpil YÜKSEL, PhD principal investigator
Necmettin Erbakan University
Didem KANDEMİR, PhD principal investigator
England
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupressure in people with Pain, Postoperative and Anxiety, run by Mersin 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 12 inclusion and 12 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 24 Apr 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. Some participants in this study may receive a placebo. 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?
Change from baseline in Pain on the Visual Analog Scale at 15 minutes (time frame: Baseline and 15 minutes). 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 NCT05875337, 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 24 Apr 2025.