Postoperative ComplicationsNCT05003284
Effect of Acupressure Application on Patients' Nausea, Vomiting, Pain, and Sleep Quality
A study testing acupressure wristband in people with Postoperative Complications, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to determine the effect of acupressure on nausea, vomiting, pain, and sleep quality after laparoscopic cholecystectomy. This was a randomized controlled experimental study with a placebo group. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- acupressure wristband
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 188 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2019to 25 Dec 2020
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients between the ages of 18 and 65 years,
- Underwent laparoscopic cholecystectomy under general anesthesia,
- Conscious, were able to communicate, had no hearing or speech problems,
- Volunteered to participate were included in the study.
Who cannot join
- Patients who left the study at any stage,
- Taken to the intensive care unit in the early postoperative period, or underwent extra surgical interventions (e.g., hernia repair, etc.) were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Acupressure Application on Patients' Nausea, Vomiting, Pain, and Sleep Quality After Laparoscopic Cholecystectomy: A Randomized Placebo-controlled Study
This study was conducted to determine the effect of acupressure on nausea, vomiting, pain, and sleep quality after laparoscopic cholecystectomy. This was a randomized controlled experimental study with a placebo group. The sample comprised 188 patients who underwent laparoscopic cholecystectomy (control:64; experimental:64; and placebo:60). Acupressure was performed on the experimental and placebo groups with a wristband for 24 hours.
Read the detailed description
Despite scientific developments and the antiemetic and analgesic drugs used, postoperative nausea, vomiting, and pain continue to be major problems affecting patients today. Many different pharmacological approaches have been developed to minimize postoperative nausea, vomiting, and pain. However, the side effects associated with traditional antiemetics and analgesics and the high cost of drugs have resulted in an increase in the use of non-pharmacological methods. Acupressure, one of such non-pharmacological methods, is based in traditional Chinese medicine. It is a treatment method that ensures proper functioning of energy channels through the application of pressure to the acupressure points on the meridians carrying energy in the body using palms, fingers, or special stimulation bands. Acupressure is an application included in the classification of nursing interventions. In the classification of nursing interventions, it is stated that acupressure is effective in relief, reduction of pain, elimination and prevention of nausea, and it is recommended to be applied to patients. Acupressure supports the independent role of nurses and provides evidence-based practice for nurses in symptom management.
Acupressure is a noninvasive, easy-to-apply, safe, low-cost application with no side effects. Thus, it is a complementary alternative treatment method that is increasingly used in the prophylaxis and treatment of postoperative nausea and vomiting due to the absence of drug-related side effects and pain and better tolerability in patients. Most of the non-pharmacological studies on the reduction of nausea and vomiting focus on the stimulation of the Pericardium 6 (PC6) acupressure point at the wrist. The nervous system is activated by the stimulation of the PC6 point on the pericardium meridian, and this system sends signals to the brain, which results in an antiemetic effect. After the brain is stimulated, neurotransmitters such as serotonin, dopamine, and endorphins are secreted. These substances prevent nausea and vomiting by blocking chemicals that can cause nausea. Acupressure is also a frequently used non-pharmacological method for reducing pain and regulating sleep. The endorphins and serotonin secreted by the stimulation of acupressure points create a calming response in the body, reduce anxiety, induce relaxation, and improve sleep quality. In addition, acupressure stimulation regulates parasympathetic nervous system activity. This situation increases sleep quality by providing an increase in autonomous responses and a decrease in psychological stress.
This study was conducted to determine the effect of acupressure on nausea, vomiting, pain, and sleep quality after laparoscopic cholecystectomy. This was a randomized controlled experimental study with a placebo group. The sample comprised 188 patients who underwent laparoscopic cholecystectomy (control:64; experimental:64; and placebo:60).
IMPACT STATEMENT What is already known on this subject? Nausea, vomiting, pain and insomnia in the postoperative period may cause discomfort, and this may adversely affect the patient's compliance with the treatment. Managing nausea, vomiting and pain in the postoperative period and improving the quality of sleep are among the important responsibilities of nurses. Thus, acupressure, as a complementary alternative method, can be recommended to reduce nausea and vomiting and improve sleep quality after surgical intervention. Acupressure is effective in relief, reduction of pain, and relief and prevention of nausea and vomiting. Acupressure supports the independent roles of nurses, provides evidence-based practice to nurses in symptom management, and improves patient-nurse relationships.
What the implications are of these findings for clinical practice and/or further research? This study is important because it shows that acupressure can be used as a complementary and alternative method in the postoperative period. Although it is reported that acupressure, which is a safe and effective method, can reduce the rate of complications, increase patient comfort, and thus affect the success of the surgical process when applied before or after surgical intervention, more evidence-based studies are needed to clearly demonstrate its effectiveness.
- Conditions
- Postoperative Complications
- Being tested
- acupressure wristband, placebo wristband
- Keywords
- acupressure, nausea-vomiting, nurse, pain, PC6, sleep
- Medical subject headings
- Postoperative Complications, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupressure wristbandDevice
acupressure after surgery
placebo wristbandDevice
acupressure after surgery
| Study group | Role | What they receive |
|---|---|---|
| acupressure wristband | Experimental | On the day before the surgery, the patients in the experimental groups were introduced to the wristband and given an explanation regarding how it should be used. Approximately 30 minutes before the experimental group patients went to surgery, the PC6 acupressure point was determined for the patients. Immediately after the experimental group patients were taken to the wards after surgery, wristbands were placed on both wrists. İt was stated to the patients that the wristbands should remain on for 24 hours. The wristband was removed at the end of the 24th hour. Receives: Device: acupressure wristband |
| placebo wristband | Placebo comparator | On the day before the surgery, the patients in the placebo groups were introduced to the wristband and given an explanation regarding how it should be used. Approximately 30 minutes before the placebo group patients went to surgery, the PC6 acupressure point was determined for the patients. Right after their surgery, patients in the placebo group were fitted with a wristband that looked the same as the acupressure wristband but did not have an acupressure application head. İt was stated to the patients that the wristbands should remain on for 24 hours. The wristband was removed at the end of the 24th hour. Receives: Device: placebo wristband |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric nausea scale.
The numeric nausea scale is a self-reported scale from 0 to 10, with 0 indicating "no nausea" and 10 indicating "very severe nausea" The highest nausea severity felt by the patient is marked on the scale
Measured: up to 24 hours
Visual analog scale
The visual analog scale was used to evaluate the pain severity of the patient. It is a self-reported scale in the form of a 10-cm ruler indicating no pain at one end and unbearable pain at the other. Accordingly, the patient is told to evaluate his/her pain between 0 and 10, with 0 indicating "no pain" and 10 indicating "unbearable pain
Measured: up to 24 hours
Verbal category scale.
The verbal category scale is a one-dimensional, simple, descriptive scale. Patients are asked to state the most appropriate word to describe their pain while filling in the scale. To describe the severity of pain, the patients had to choose from among (1) mild, (2) disturbing, (3) severe, (4) very severe, and (5) unbearable
Measured: up to 24 hours
Richards-Campbell Sleep Questionnaire
Richards-campbell sleep questionnaire evaluates the depth of night sleep, sleep latency, number of awakenings, return to sleep, sleep quality, and the level of noise in the environment. It consists of six questions in total. Each item of the scale is evaluated with a visual analog scale ranging from 0 to 100. In this scale, "0-25" points indicate "very poor sleep" and "76-100" points indicate "very good sleep."
Measured: To collect data on sleep, richards-campbell sleep questionnaire was applied to all three groups 24 hours after surgery to evaluate sleep, and the responses were recorded
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start1 Nov 2019
- Primary completion1 Nov 2020
- Study completion25 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by Ataturk 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
- Masking
- None (open label)
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tülay KILINÇ, Ataturk University
- Investigators
- Tülay kılınç, Dr, Principal investigator, Ataturk Unıversty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05003284
- Sponsor's protocol ID
- tulay25
- Status last verified
- Aug 2021
- First submitted
- 25 Jun 2021
- Last updated
- 12 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acupressure Application on Patients' Nausea, Vomiting, Pain, and Sleep Quality After Laparoscopic Cholecystectomy: A Randomized Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT05003284
- Acronym / sponsor ID
- tulay25
- Conditions
- Postoperative Complications
- Keywords
- acupressure, nausea-vomiting, nurse, pain, PC6, sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 25 Dec 2020 (actual)
- First posted
- 12 Aug 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.
This study was conducted to determine the effect of acupressure on nausea, vomiting, pain, and sleep quality after laparoscopic cholecystectomy. This was a randomized controlled experimental study with a placebo group. The sample comprised 188 patients who underwent laparoscopic cholecystectomy (control:64; experimental:64; and placebo:60). Acupressure was performed on the experimental and placebo groups with a wristband for 24 hours.
Detailed description
Despite scientific developments and the antiemetic and analgesic drugs used, postoperative nausea, vomiting, and pain continue to be major problems affecting patients today. Many different pharmacological approaches have been developed to minimize postoperative nausea, vomiting, and pain. However, the side effects associated with traditional antiemetics and analgesics and the high cost of drugs have resulted in an increase in the use of non-pharmacological methods. Acupressure, one of such non-pharmacological methods, is based in traditional Chinese medicine. It is a treatment method that ensures proper functioning of energy channels through the application of pressure to the acupressure points on the meridians carrying energy in the body using palms, fingers, or special stimulation bands. Acupressure is an application included in the classification of nursing interventions. In the classification of nursing interventions, it is stated that acupressure is effective in relief, reduction of pain, elimination and prevention of nausea, and it is recommended to be applied to patients. Acupressure supports the independent role of nurses and provides evidence-based practice for nurses in symptom management.
Acupressure is a noninvasive, easy-to-apply, safe, low-cost application with no side effects. Thus, it is a complementary alternative treatment method that is increasingly used in the prophylaxis and treatment of postoperative nausea and vomiting due to the absence of drug-related side effects and pain and better tolerability in patients. Most of the non-pharmacological studies on the reduction of nausea and vomiting focus on the stimulation of the Pericardium 6 (PC6) acupressure point at the wrist. The nervous system is activated by the stimulation of the PC6 point on the pericardium meridian, and this system sends signals to the brain, which results in an antiemetic effect. After the brain is stimulated, neurotransmitters such as serotonin, dopamine, and endorphins are secreted. These substances prevent nausea and vomiting by blocking chemicals that can cause nausea. Acupressure is also a frequently used non-pharmacological method for reducing pain and regulating sleep. The endorphins and serotonin secreted by the stimulation of acupressure points create a calming response in the body, reduce anxiety, induce relaxation, and improve sleep quality. In addition, acupressure stimulation regulates parasympathetic nervous system activity. This situation increases sleep quality by providing an increase in autonomous responses and a decrease in psychological stress.
This study was conducted to determine the effect of acupressure on nausea, vomiting, pain, and sleep quality after laparoscopic cholecystectomy. This was a randomized controlled experimental study with a placebo group. The sample comprised 188 patients who underwent laparoscopic cholecystectomy (control:64; experimental:64; and placebo:60).
IMPACT STATEMENT What is already known on this subject? Nausea, vomiting, pain and insomnia in the postoperative period may cause discomfort, and this may adversely affect the patient's compliance with the treatment. Managing nausea, vomiting and pain in the postoperative period and improving the quality of sleep are among the important responsibilities of nurses. Thus, acupressure, as a complementary alternative method, can be recommended to reduce nausea and vomiting and improve sleep quality after surgical intervention. Acupressure is effective in relief, reduction of pain, and relief and prevention of nausea and vomiting. Acupressure supports the independent roles of nurses, provides evidence-based practice to nurses in symptom management, and improves patient-nurse relationships.
What the implications are of these findings for clinical practice and/or further research? This study is important because it shows that acupressure can be used as a complementary and alternative method in the postoperative period. Although it is reported that acupressure, which is a safe and effective method, can reduce the rate of complications, increase patient comfort, and thus affect the success of the surgical process when applied before or after surgical intervention, more evidence-based studies are needed to clearly demonstrate its effectiveness.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acupressure wristband | Experimental | Device: acupressure wristbandOn the day before the surgery, the patients in the experimental groups were introduced to the wristband and given an explanation regarding how it should be used. Approximately 30 minutes before the experimental group patients went to surgery, the PC6 acupressure point was determined for the patients. Immediately after the experimental group patients were taken to the wards after surgery, wristbands were placed on both wrists. İt was stated to the patients that the wristbands should remain on for 24 hours. The wristband was removed at the end of the 24th hour. |
| placebo wristband | Placebo comparator | Device: placebo wristbandOn the day before the surgery, the patients in the placebo groups were introduced to the wristband and given an explanation regarding how it should be used. Approximately 30 minutes before the placebo group patients went to surgery, the PC6 acupressure point was determined for the patients. Right after their surgery, patients in the placebo group were fitted with a wristband that looked the same as the acupressure wristband but did not have an acupressure application head. İt was stated to the patients that the wristbands should remain on for 24 hours. The wristband was removed at the end of the 24th hour. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients between the ages of 18 and 65 years,
- Underwent laparoscopic cholecystectomy under general anesthesia,
- Conscious, were able to communicate, had no hearing or speech problems,
- Volunteered to participate were included in the study.
Key exclusion criteria (2 listed)
- Patients who left the study at any stage,
- Taken to the intensive care unit in the early postoperative period, or underwent extra surgical interventions (e.g., hernia repair, etc.) were excluded from the study.
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 |
|---|---|---|
| acupressure wristbandacupressure after surgery | Device | acupressure wristband |
| placebo wristbandacupressure after surgery | Device | placebo wristband |
Primary outcome
Numeric nausea scale.
Time frame: up to 24 hours
The numeric nausea scale is a self-reported scale from 0 to 10, with 0 indicating "no nausea" and 10 indicating "very severe nausea" The highest nausea severity felt by the patient is marked on the scale
Visual analog scale
Time frame: up to 24 hours
The visual analog scale was used to evaluate the pain severity of the patient. It is a self-reported scale in the form of a 10-cm ruler indicating no pain at one end and unbearable pain at the other. Accordingly, the patient is told to evaluate his/her pain between 0 and 10, with 0 indicating "no pain" and 10 indicating "unbearable pain
Verbal category scale.
Time frame: up to 24 hours
The verbal category scale is a one-dimensional, simple, descriptive scale. Patients are asked to state the most appropriate word to describe their pain while filling in the scale. To describe the severity of pain, the patients had to choose from among (1) mild, (2) disturbing, (3) severe, (4) very severe, and (5) unbearable
Richards-Campbell Sleep Questionnaire
Time frame: To collect data on sleep, richards-campbell sleep questionnaire was applied to all three groups 24 hours after surgery to evaluate sleep, and the responses were recorded
Richards-campbell sleep questionnaire evaluates the depth of night sleep, sleep latency, number of awakenings, return to sleep, sleep quality, and the level of noise in the environment. It consists of six questions in total. Each item of the scale is evaluated with a visual analog scale ranging from 0 to 100. In this scale, "0-25" points indicate "very poor sleep" and "76-100" points indicate "very good sleep."
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 12 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tülay kılınç, Dr principal investigator
Ataturk Unıversty
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 wristband in people with Postoperative Complications, run by Ataturk 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 4 inclusion and 2 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 12 Aug 2021. 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?
Numeric nausea scale. (time frame: up to 24 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2021.