AcupressureDBNCT06468345
Acupressure Application in Obesity Surgery 2345
A study testing acupressure and Area different from acupressure area in people with Acupressure and Bariatric Surgery, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
This research was conducted to determine the effect of acupressure applied to patients after bariatric surgery on gastrointestinal distress, pain and anxiety. The data of the study was collected at Aktif Private Kocaeli Hospital General Surgery Clinic between January 2022 and February 2023. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Acupressure, Bariatric Surgery, Spleen Meridian
- What is being tested?
- acupressure and Area different from acupressure area
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 15 Mar 2023
- 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 undergoing Bariatric Surgery
- Conscious patients between the ages of 18-65
- Patients who can communicate
- Patients without hearing-speech problems
- Patients without any psychiatric disorder
- Patients willing to cooperate
- Patients who have never had acupressure before
- Patients who do not have conditions such as hematoma, wound or fracture in the areas where acupressure will be applied
Who cannot join
- Patients who withdraw from the study at any stage of the study
- Patients admitted to the intensive care unit in the early postoperative period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Acupressure Applied After Bariatric Surgery on Gastrointestinal Functions, Pain and Anxiety
This research was conducted to determine the effect of acupressure applied to patients after bariatric surgery on gastrointestinal distress, pain and anxiety. The data of the study was collected at Aktif Private Kocaeli Hospital General Surgery Clinic between January 2022 and February 2023. The study was conducted with 90 (30 control, 30 intervention and 30 placebo) patients who underwent bariatric surgery. As a result of the research, application to ST25 and CV12 acupressure areas after bariatric surgery increased gas and stool output. It reduced abdominal distension. This enabled patients to start oral intake early. Application to the SP6 area reduced abdominal pain. Acupressure applied to the LI4 area was not effective in reducing nausea and vomiting. Massage to the HT7 acupressure area alone was not sufficient to relieve anxiety.
Read the detailed description
This research was conducted to determine the intensity of acupressure treatment for gastrointestinal problems, pain and anxiety after bariatric surgery. The research was conducted using a placebo group, randomized controlled, detailed research model. The data of the study was collected at Aktif Private Kocaeli Hospital General Surgery Clinic between January 2022 and February 2023. The study was conducted with 90 (30 control, 30 intervention and 30 placebo) patients who underwent bariatric surgery. The data were brought together with the patient identification formula, postoperative gastrointestinal functions information formula, abdominal distension formula, visual analog scale, state-trait anxiety inventory scale, visual comparison operation, and patient happiness formula. The data were analyzed with the SPSS for Windows 22 package program. Records of numbers, percentages, minimum and maximum values, averages and standard deviations in the analysis of data. Mann Whitney U analysis, LSD, Dunnet C, Kruskall Wallis, Will coxon analyzes and t test records. The results were interpreted at the p< 0.05 significance level. Gastrointestinal capacity and recovery time, stool and gas output rates, difference in distension and abdominal pain score amounts, oral intake amounts and retching difference of the patients in acupressure, control and placebo distribution at the 6th, 12th, 24th and 48th months of the surgery were investigated. Children's movements and vomiting were evaluated with visual comparison performance. Anxiety was measured with the State-Trait Anxiety Inventory Scale at the ages of 6, 12, 24 and 48 after treatment. He recorded the Patient Satisfaction Form to obtain the patients' satisfaction after acupressure.
- Being tested
- acupressure, Area different from acupressure area
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupressureBehavioural
Application was made to CV12, ST25, SP6, HT7 and LI4 acupressure areas.
Area different from acupressure areaBehavioural
Massage application to non-acupressure hand, foot and abdominal areas
| Study group | Role | What they receive |
|---|---|---|
| Acupressure Group | Experimental | Acupressure application to CV12, ST25, SP6, LI4 and HT7 areas Receives: Behavioral: acupressure |
| Control Group | No intervention | No action was taken. |
| Placebo Group | Sham comparator | Massage application to feet, hands and abdomen areas that are not acupressure areas Receives: Behavioral: Area different from acupressure area |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of pain after obesity surgery in the intervention, placebo and control groups with the Visual Analog pain scale
On the Visual Analog pain scale, a score of 0 means no pain and 10 means unbearable pain.
Measured: Pain was assessed at 24 hours postoperatively.
Secondary outcomes (1)
Evaluating the distension of patients after obesity surgery with the Abdominal Distension Form
The Abdominal Distension Form ranges from 0 to no distension and 10 to severe distension.
Measured: Distention of the patients was measured at the 24th postoperative hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start1 Jan 2022
- Primary completion20 Feb 2023
- Study completion15 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcupressureStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duygu Balaban, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06468345
- Sponsor's protocol ID
- DBalaban
- Acronym
- DB
- Status last verified
- Jun 2024
- First submitted
- 22 May 2024
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acupressure Applied After Bariatric Surgery on Gastrointestinal Functions, Pain and Anxiety
- ClinicalTrials.gov ID
- NCT06468345
- Acronym / sponsor ID
- DB / DBalaban
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 20 Feb 2023 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 21 Jun 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.
This research was conducted to determine the effect of acupressure applied to patients after bariatric surgery on gastrointestinal distress, pain and anxiety. The data of the study was collected at Aktif Private Kocaeli Hospital General Surgery Clinic between January 2022 and February 2023. The study was conducted with 90 (30 control, 30 intervention and 30 placebo) patients who underwent bariatric surgery. As a result of the research, application to ST25 and CV12 acupressure areas after bariatric surgery increased gas and stool output. It reduced abdominal distension. This enabled patients to start oral intake early. Application to the SP6 area reduced abdominal pain. Acupressure applied to the LI4 area was not effective in reducing nausea and vomiting. Massage to the HT7 acupressure area alone was not sufficient to relieve anxiety.
Detailed description
This research was conducted to determine the intensity of acupressure treatment for gastrointestinal problems, pain and anxiety after bariatric surgery. The research was conducted using a placebo group, randomized controlled, detailed research model. The data of the study was collected at Aktif Private Kocaeli Hospital General Surgery Clinic between January 2022 and February 2023. The study was conducted with 90 (30 control, 30 intervention and 30 placebo) patients who underwent bariatric surgery. The data were brought together with the patient identification formula, postoperative gastrointestinal functions information formula, abdominal distension formula, visual analog scale, state-trait anxiety inventory scale, visual comparison operation, and patient happiness formula. The data were analyzed with the SPSS for Windows 22 package program. Records of numbers, percentages, minimum and maximum values, averages and standard deviations in the analysis of data. Mann Whitney U analysis, LSD, Dunnet C, Kruskall Wallis, Will coxon analyzes and t test records. The results were interpreted at the p< 0.05 significance level. Gastrointestinal capacity and recovery time, stool and gas output rates, difference in distension and abdominal pain score amounts, oral intake amounts and retching difference of the patients in acupressure, control and placebo distribution at the 6th, 12th, 24th and 48th months of the surgery were investigated. Children's movements and vomiting were evaluated with visual comparison performance. Anxiety was measured with the State-Trait Anxiety Inventory Scale at the ages of 6, 12, 24 and 48 after treatment. He recorded the Patient Satisfaction Form to obtain the patients' satisfaction after acupressure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acupressure Group | Experimental | Behavioral: acupressureAcupressure application to CV12, ST25, SP6, LI4 and HT7 areas |
| Control Group | No intervention | –No action was taken. |
| Placebo Group | Sham comparator | Behavioral: Area different from acupressure areaMassage application to feet, hands and abdomen areas that are not acupressure areas |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients undergoing Bariatric Surgery
- Conscious patients between the ages of 18-65
- Patients who can communicate
- Patients without hearing-speech problems
- Patients without any psychiatric disorder
Key exclusion criteria (2 listed)
- Patients who withdraw from the study at any stage of the study
- Patients admitted to the intensive care unit in the early postoperative period
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 |
|---|---|---|
| acupressureApplication was made to CV12, ST25, SP6, HT7 and LI4 acupressure areas. | Behavioural | Acupressure Group |
| Area different from acupressure areaMassage application to non-acupressure hand, foot and abdominal areas | Behavioural | Placebo Group |
Primary outcome
Evaluation of pain after obesity surgery in the intervention, placebo and control groups with the Visual Analog pain scale
Time frame: Pain was assessed at 24 hours postoperatively.
On the Visual Analog pain scale, a score of 0 means no pain and 10 means unbearable pain.
1 secondary outcome
Evaluating the distension of patients after obesity surgery with the Abdominal Distension Form
Time frame: Distention of the patients was measured at the 24th postoperative hour.
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 21 Jun 2024.
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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 acupressure and Area different from acupressure area in people with Acupressure and Bariatric Surgery, 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 8 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 21 Jun 2024. 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?
Evaluation of pain after obesity surgery in the intervention, placebo and control groups with the Visual Analog pain scale (time frame: Pain was assessed at 24 hours postoperatively.). 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 21 Jun 2024.