Gastrointestinal DysfunctionNCT04606485
Does Acupressure Affect Gastrointestinal Function, Pain and Anxiety?
A study testing Acupressure in people with Gastrointestinal Dysfunction and Anxiety, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this randomised, placebo-controlled, 3-way blinded study was to determine the effect on GIS symptoms, pain and anxiety of acupressure applied for a total of 12 mins, as 3 mins at each of the ST25, CV12, TH6 and HT7 acupuncture points, at 0, 4 and 8 hours after laparoscopic cholecystectomy operation. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Dysfunction, Anxiety, Pain, Postoperative
- What is being tested?
- Acupressure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2018to 1 May 2019
- 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
- Age 18-75 years
- Able to understand the information given
- Willing to receive acupressure
- No lesions or wounds in the areas where acupressure was to be applied
- Operated on under general anaesthesia pulse, blood pressure, body temperature and oxygen saturation values within normal range during the operation
- No failure or disorder developing intraoperatively or postoperatively related to fluid-electrolyte balance, acid-base balance, or tissue perfusion.
Who cannot join
- American Society of Anaesthesiologists (ASA) physical status IV
- A requirement for simultaneous combined surgery,
- A need for postoperative fasting according to the preoperative evaluation or intraoperative findings (eg, panperitonitis with intraperitoneal abscess)
- Patients with a cardiac pacemaker
- A history of syncope or seizures
- Pregnant or lactating women
- The presence of any disease related to bleeding or a clotting disorder
- Patients who were unwilling to participate in the research.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect On Gastrointestinal System Functions, Pain And Anxiety Of Acupressure Applied Following Laparoscopic Cholecystectomy Operation: A Randomised, Placebo-Controlled Study
The aim of this randomised, placebo-controlled, 3-way blinded study was to determine the effect on GIS symptoms, pain and anxiety of acupressure applied for a total of 12 mins, as 3 mins at each of the ST25, CV12, TH6 and HT7 acupuncture points, at 0, 4 and 8 hours after laparoscopic cholecystectomy operation. The research data were collected using a patient data collection form, the Numeric Pain Intensity Scale and the State-Trait Anxiety Inventory. The patients were evaluated in respect of the time to first flatus and defecation, pain and the State-Trait Anxiety points at 0, 4, and 8 hours postoperatively.
Read the detailed description
Together with technological advances in the field of healthcare, there is currently a greater preference for the laparoscopic cholecystectomy procedure, as length of hospital stay is shorter, workforce loss is lower, good cosmetic results are obtained and postoperative patient satisfaction is higher, when compared to open cholecystectomy.
One of the basic factors affecting the patient is the anesthesia applied in the laparoscopic surgical approach. Following general anaesthesia, metabolic activity slows and gastrointestinal system (GIS) movements are reduced. In addition, by increasing intra-abdominal pressure, the gas insufflation applied to the peritoneal cavity in laparoscopic surgery, reduces blood flow in the stomach and small and large intestines. As a result of this reduced blood flow, ischemia and dysfunction in the intestines may cause ileus symptoms to emerge. Pain occuring as a response to surgical stress causes a decrease in intestinal motility. If pain is not brought under control postoperatively, nausea, vomiting, constipation and ileus may occur.
Preoperative anxiety has been reported to be associated with postoperative pain, cognitive disorders and delayed healing. Stress reaction, surgical intervention to the abdominal region, trauma, postoperative pain, and the use of anaesthetic and narcotic agents are among the factors causing the development of GIS problems. An increase in sympathetic activity which occurs in the stress reaction and the use of general/narcotic anaesthesia reduce gastrointestinal motility. Pharmacological treatments are applied to improve GIS functions. It has been reported that intravenous infusion of lidocaine in the perioperative period provides a faster recovery of bowel functions. Postoperative gastrointestinal dysfunction is usually treated using alvimopan, but the drug used has side effects such as nausea and vomiting. Postoperative pain and nausea-vomiting are common complaints after laparoscopic cholecystectomy, despite the use of multimodal analgesia consisting of dexamethasone, opioids, nonsteroidal anti-inflammatory drugs and local anesthetics used in the perioperative period. In addition, of the nursing applications used, the application of acupressure is of benefit. Acupressure is accepted as a non-invasive application that can easily be applied by trained nurses, which increases the quality of the medical care administered and contributes to physical and psychological recovery. In studies of acupressure applied for the recovery of GIS functions, it has been reported that acupressure can be applied as non-invasive nursing care which improves postoperative ileus symptoms.
In a study by Chao et al, acupressure applied after abdominal surgery was reported to improve gas output, shorten the time to oral nutritional intake, and improve ileus symptoms. Acupressure applied to the P6 point following appendectomy decreased the frequency of vomiting. In another study, acupressure was determined to be effective in improving GIS movement. Acupressure improved intestinal functions but stated that more experimental studies were needed.
It is recommended to teach the use of acupuncture warning devices to patients with post-operative nausea, vomiting and anxiety problems. However, there is no definitive evidence as to when, how and for how long acupressure should be administered. Moreover, studies conducted by nurses on this subject are limited and studies with high evidence value are needed. As a result of our literature review, the effect of acupressure applied to ST25, CV12, TH6 and HT7 on bowel movements, first flatus and defecation time, pain and anxiety after laparoscopic cholecystectomy was not investigated. Therefore, our study was carried out to evaluate the effect of acupressure applied to patients after laparoscopic cholecystectomy on GIS functions, pain and anxiety.
- Conditions
- Gastrointestinal Dysfunction, Anxiety, Pain, Postoperative
- Being tested
- Acupressure
- Keywords
- Acupressure, Gastrointestinal Dysfunction, Anxiety, Pain
- Medical subject headings
- Anxiety Disorders, Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupressureOther
Acupressure is accepted as a non-invasive application that can easily be applied by trained nurses, which increases the quality of the medical care administered and contributes to physical and psychological recovery.
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | Since acupressure administration was reported to have placebo effects, a placebo group was used to investigate the true effect of acupressure use. The application of placebo may consist of moderate pressure on an incorrect acupuncture point or a light touch on a real acupuncture point. This will allow us to determine the contribution of the placebo effect resulting from direct human contact and interaction in the light touch group.
At postoperative 0, 4, and 8 hours, a light touch was applied to the ST25 (Stomach Meridian 25th point), CV12 (Conception Vessel Meridian 12th point), TH6 (Triple Heater Meridian 6th point) and HT7 (Shenmen point points) for one second. No patients experienced pain or a feeling of pressure. Receives: Other: Acupressure |
| Experimental group | Experimental | As invasive acupuncture may cause hematoma and the wristband method of non-invasive acupressure may cause patient discomfort, itching, swelling of the wrist, and skin destruction, manual acupressure was applied in this study to reduce the risk of complications to a minimum.
The frequency and duration of the application of acupressure was decided from a scan of literature and expert opinion. The first acupressure session was applied in the first postoperative hour immediately after routine treatment and care of the patients who came to the ward from the recovery unit. Acupressure by applying pressure with the thumbs for a total of 12 mins, as 3 mins at each of the ST25, CV12, TH6 and HT7 acupuncture points, was performed at 0, 4 and 8 hours postoperatively. The acupuncture points were determined using the measurements of the patient's own fingers. Receives: Other: Acupressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the first flatus process according to the information received from the patient
First flatus hour is validated, the patient was questioned about the time of flatus output. The hour reported by the patient was evaluated as the time of first flatus. Change=(Postoperative 0 and 72 hours).
Measured: Postoperative 0 and 72 hours
Change in the first gaits output process according to the information received from the patient
First gaits output is validated, the patient was questioned about the time of gaits output. The hour reported by the patient was evaluated as the time of first gaits.Change=(Postoperative 0 and 72 hours).
Measured: Postoperative 0 and 72 hours
Change from Baseline in Pain on The Numeric Pain Intensity Scale (NAS) at postoperative 0, 4 and 8 hours.
NAS is a single dimension, subjective scale, consisting of a horizontal line, marked at equal intervals from 0-10, where 0= no pain and 10= intolerable pain. The scores were evaluated as 1-3 represents mild pain, 4-6 moderate pain, and 7-10 severe pain. The patients were instructed to mark the number best reflecting the level of pain felt.It was evaluated 4 times in total before acupressure, at the postoperative 0, 4 and 8 hours after the acupressure application. Change=(pre-acupressure score- postoperative 0, 4 and 8 hours scores).
Measured: Pre-acupressure, postoperative 0, 4 and 8 hours
Change from Baseline The State-Trait Anxiety Inventory (SAI) at pre-acupressure and postoperative 8 hour
The State-Trait Anxiety Inventory was developed by Spielberger in 1964 and was adapted to Turkish by Öner and LeCompte. The scale, which is self-reported and consists of short statements, measures the levels of anxiety of both patients and healthy individuals. The State Anxiety Inventory (SAI) provides information about how the individual feels at that time, and the Trait Anxiety Inventory (TAI) about how they have felt in the last 7 days.
The constant value is 50 for the SAI and 35 for the TAI. The most recently obtained value constitutes the anxiety points, in a maximum range of 20-80, with high scores indicating a high level of anxiety. Change= (Pre-acupressure score and postoperative 8 hour score).
Measured: Pre-acupressure and postoperative 8 hour
Secondary outcomes (2)
Change from Baseline in Nause on The Nause Intensity Scale (VAS) at pre-acupressure, postoperative 0, 4 and 8 hours.
A 10 cm scale, marked in cm, where 0= no nausea and 10= very severe nausea was used and each patient was instructed to mark the greatest severity of nausea that they had felt on the scale. It was evaluated 4 times in total before acupressure, at the postoperative 0, 4 and 8 hours after the acupressure application. Change=(pre-acupressure score- postoperative 0, 4 and 8 hours score).
Measured: Pre-acupressure, postoperative 0, 4 and 8 hours
Change from Baseline in intestinal sounds at pre-acupressure, postoperative 0, 4 and 8 hours.
Intestinal sounds were listened to with the same stethoscope, by dividing the abdomen into 4 quadrants and evaluating each quadrant. A time of one minute was set on a chronometer for each evaluation, and the number of the intestinal sounds in one minute were counted and recorded. It was evaluated 4 times in total before acupressure, at the postoperative 0, 4 and 8 hours after the acupressure application. Change=(pre-acupressure number- postoperative 0, 4 and 8 hours numbers).
Measured: Pre-acupressure, postoperative 0, 4 and 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start1 May 2018
- Primary completion1 May 2019
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal DysfunctionStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Di̇lek Soylu, Kahramanmaras Sutcu Imam University
- Investigators
- Di̇lek Soylu, Principal investigator, Kahramanmaras Sutcu Imam universty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04606485
- Sponsor's protocol ID
- Interventional
- Status last verified
- Oct 2020
- First submitted
- 13 Oct 2020
- Last updated
- 28 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Our study has not been published yet
Publications
Abadi F, Shahabinejad M, Abadi F, Kazemi M. Effect of Acupressure on Symptoms of Postoperative Ileus After Cesarean Section. J Acupunct Meridian Stud. 2017 Apr;10(2):114-119. doi: 10.1016/j.jams.2016.11.008. Epub 2016 Dec 27.
PubMed 28483182Chao HL, Miao SJ, Liu PF, Lee HH, Chen YM, Yao CT, Chou HL. The beneficial effect of ST-36 (Zusanli) acupressure on postoperative gastrointestinal function in patients with colorectal cancer. Oncol Nurs Forum. 2013 Mar;40(2):E61-8. doi: 10.1188/13.ONF.E61-E68.
PubMed 23448746Adib-Hajbaghery M, Etri M, Hosseainian M, Mousavi MS. Pressure to the p6 acupoint and post-appendectomy pain, nausea, and vomiting: a randomized clinical trial. J Caring Sci. 2013 Jun 1;2(2):115-22. doi: 10.5681/jcs.2013.014. eCollection 2013 Jun.
PubMed 25276717Chen LL, Hsu SF, Wang MH, Chen CL, Lin YD, Lai JS. Use of acupressure to improve gastrointestinal motility in women after trans-abdominal hysterectomy. Am J Chin Med. 2003;31(5):781-90. doi: 10.1142/S0192415X03001466.
PubMed 14696681
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect On Gastrointestinal System Functions, Pain And Anxiety Of Acupressure Applied Following Laparoscopic Cholecystectomy Operation: A Randomised, Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT04606485
- Acronym / sponsor ID
- Interventional
- Conditions
- Gastrointestinal Dysfunction, Anxiety, Pain, Postoperative
- Keywords
- Acupressure, Gastrointestinal Dysfunction, Anxiety, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 28 Oct 2020 (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 aim of this randomised, placebo-controlled, 3-way blinded study was to determine the effect on GIS symptoms, pain and anxiety of acupressure applied for a total of 12 mins, as 3 mins at each of the ST25, CV12, TH6 and HT7 acupuncture points, at 0, 4 and 8 hours after laparoscopic cholecystectomy operation. The research data were collected using a patient data collection form, the Numeric Pain Intensity Scale and the State-Trait Anxiety Inventory. The patients were evaluated in respect of the time to first flatus and defecation, pain and the State-Trait Anxiety points at 0, 4, and 8 hours postoperatively.
Detailed description
Together with technological advances in the field of healthcare, there is currently a greater preference for the laparoscopic cholecystectomy procedure, as length of hospital stay is shorter, workforce loss is lower, good cosmetic results are obtained and postoperative patient satisfaction is higher, when compared to open cholecystectomy.
One of the basic factors affecting the patient is the anesthesia applied in the laparoscopic surgical approach. Following general anaesthesia, metabolic activity slows and gastrointestinal system (GIS) movements are reduced. In addition, by increasing intra-abdominal pressure, the gas insufflation applied to the peritoneal cavity in laparoscopic surgery, reduces blood flow in the stomach and small and large intestines. As a result of this reduced blood flow, ischemia and dysfunction in the intestines may cause ileus symptoms to emerge. Pain occuring as a response to surgical stress causes a decrease in intestinal motility. If pain is not brought under control postoperatively, nausea, vomiting, constipation and ileus may occur.
Preoperative anxiety has been reported to be associated with postoperative pain, cognitive disorders and delayed healing. Stress reaction, surgical intervention to the abdominal region, trauma, postoperative pain, and the use of anaesthetic and narcotic agents are among the factors causing the development of GIS problems. An increase in sympathetic activity which occurs in the stress reaction and the use of general/narcotic anaesthesia reduce gastrointestinal motility. Pharmacological treatments are applied to improve GIS functions. It has been reported that intravenous infusion of lidocaine in the perioperative period provides a faster recovery of bowel functions. Postoperative gastrointestinal dysfunction is usually treated using alvimopan, but the drug used has side effects such as nausea and vomiting. Postoperative pain and nausea-vomiting are common complaints after laparoscopic cholecystectomy, despite the use of multimodal analgesia consisting of dexamethasone, opioids, nonsteroidal anti-inflammatory drugs and local anesthetics used in the perioperative period. In addition, of the nursing applications used, the application of acupressure is of benefit. Acupressure is accepted as a non-invasive application that can easily be applied by trained nurses, which increases the quality of the medical care administered and contributes to physical and psychological recovery. In studies of acupressure applied for the recovery of GIS functions, it has been reported that acupressure can be applied as non-invasive nursing care which improves postoperative ileus symptoms.
In a study by Chao et al, acupressure applied after abdominal surgery was reported to improve gas output, shorten the time to oral nutritional intake, and improve ileus symptoms. Acupressure applied to the P6 point following appendectomy decreased the frequency of vomiting. In another study, acupressure was determined to be effective in improving GIS movement. Acupressure improved intestinal functions but stated that more experimental studies were needed.
It is recommended to teach the use of acupuncture warning devices to patients with post-operative nausea, vomiting and anxiety problems. However, there is no definitive evidence as to when, how and for how long acupressure should be administered. Moreover, studies conducted by nurses on this subject are limited and studies with high evidence value are needed. As a result of our literature review, the effect of acupressure applied to ST25, CV12, TH6 and HT7 on bowel movements, first flatus and defecation time, pain and anxiety after laparoscopic cholecystectomy was not investigated. Therefore, our study was carried out to evaluate the effect of acupressure applied to patients after laparoscopic cholecystectomy on GIS functions, pain and anxiety.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Other: AcupressureSince acupressure administration was reported to have placebo effects, a placebo group was used to investigate the true effect of acupressure use. The application of placebo may consist of moderate pressure on an incorrect acupuncture point or a light touch on a real acupuncture point. This will allow us to determine the contribution of the placebo effect resulting from direct human contact and interaction in the light touch group. At postoperative 0, 4, and 8 hours, a light touch was applied to the ST25 (Stomach Meridian 25th point), CV12 (Conception Vessel Meridian 12th point), TH6 (Triple Heater Meridian 6th point) and HT7 (Shenmen point points) for one second. No patients experienced pain or a feeling of pressure. |
| Experimental group | Experimental | Other: AcupressureAs invasive acupuncture may cause hematoma and the wristband method of non-invasive acupressure may cause patient discomfort, itching, swelling of the wrist, and skin destruction, manual acupressure was applied in this study to reduce the risk of complications to a minimum. The frequency and duration of the application of acupressure was decided from a scan of literature and expert opinion. The first acupressure session was applied in the first postoperative hour immediately after routine treatment and care of the patients who came to the ward from the recovery unit. Acupressure by applying pressure with the thumbs for a total of 12 mins, as 3 mins at each of the ST25, CV12, TH6 and HT7 acupuncture points, was performed at 0, 4 and 8 hours postoperatively. The acupuncture points were determined using the measurements of the patient's own fingers. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-75 years
- Able to understand the information given
- Willing to receive acupressure
- No lesions or wounds in the areas where acupressure was to be applied
- Operated on under general anaesthesia pulse, blood pressure, body temperature and oxygen saturation values within normal range during the operation
Key exclusion criteria (8 listed)
- American Society of Anaesthesiologists (ASA) physical status IV
- A requirement for simultaneous combined surgery,
- A need for postoperative fasting according to the preoperative evaluation or intraoperative findings (eg, panperitonitis with intraperitoneal abscess)
- Patients with a cardiac pacemaker
- A history of syncope or seizures
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 |
|---|---|---|
| AcupressureAcupressure is accepted as a non-invasive application that can easily be applied by trained nurses, which increases the quality of the medical care administered and contributes to physical and psychological recovery. | Other | Experimental group, Placebo group |
Primary outcome
Change in the first flatus process according to the information received from the patient
Time frame: Postoperative 0 and 72 hours
First flatus hour is validated, the patient was questioned about the time of flatus output. The hour reported by the patient was evaluated as the time of first flatus. Change=(Postoperative 0 and 72 hours).
Change in the first gaits output process according to the information received from the patient
Time frame: Postoperative 0 and 72 hours
First gaits output is validated, the patient was questioned about the time of gaits output. The hour reported by the patient was evaluated as the time of first gaits.Change=(Postoperative 0 and 72 hours).
Change from Baseline in Pain on The Numeric Pain Intensity Scale (NAS) at postoperative 0, 4 and 8 hours.
Time frame: Pre-acupressure, postoperative 0, 4 and 8 hours
NAS is a single dimension, subjective scale, consisting of a horizontal line, marked at equal intervals from 0-10, where 0= no pain and 10= intolerable pain. The scores were evaluated as 1-3 represents mild pain, 4-6 moderate pain, and 7-10 severe pain. The patients were instructed to mark the number best reflecting the level of pain felt.It was evaluated 4 times in total before acupressure, at the postoperative 0, 4 and 8 hours after the acupressure application. Change=(pre-acupressure score- postoperative 0, 4 and 8 hours scores).
Change from Baseline The State-Trait Anxiety Inventory (SAI) at pre-acupressure and postoperative 8 hour
Time frame: Pre-acupressure and postoperative 8 hour
The State-Trait Anxiety Inventory was developed by Spielberger in 1964 and was adapted to Turkish by Öner and LeCompte. The scale, which is self-reported and consists of short statements, measures the levels of anxiety of both patients and healthy individuals. The State Anxiety Inventory (SAI) provides information about how the individual feels at that time, and the Trait Anxiety Inventory (TAI) about how they have felt in the last 7 days. The constant value is 50 for the SAI and 35 for the TAI. The most recently obtained value constitutes the anxiety points, in a maximum range of 20-80, with high scores indicating a high level of anxiety. Change= (Pre-acupressure score and postoperative 8 hour score).
2 secondary outcomes
Change from Baseline in Nause on The Nause Intensity Scale (VAS) at pre-acupressure, postoperative 0, 4 and 8 hours.
Time frame: Pre-acupressure, postoperative 0, 4 and 8 hours
Change from Baseline in intestinal sounds at pre-acupressure, postoperative 0, 4 and 8 hours.
Time frame: Pre-acupressure, postoperative 0, 4 and 8 hours
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 28 Oct 2020.
- Results publication: PubMed 28483182Abadi F, Shahabinejad M, Abadi F, Kazemi M. Effect of Acupressure on Symptoms of Postoperative Ileus After Cesarean Section. J Acupunct Meridian Stud. 2017 Apr;10(2):114-119. doi: 10.1016/j.jams.2016.11.008. Epub 2016 Dec 27.
- Results publication: PubMed 23448746Chao HL, Miao SJ, Liu PF, Lee HH, Chen YM, Yao CT, Chou HL. The beneficial effect of ST-36 (Zusanli) acupressure on postoperative gastrointestinal function in patients with colorectal cancer. Oncol Nurs Forum. 2013 Mar;40(2):E61-8. doi: 10.1188/13.ONF.E61-E68.
- Results publication: PubMed 25276717Adib-Hajbaghery M, Etri M, Hosseainian M, Mousavi MS. Pressure to the p6 acupoint and post-appendectomy pain, nausea, and vomiting: a randomized clinical trial. J Caring Sci. 2013 Jun 1;2(2):115-22. doi: 10.5681/jcs.2013.014. eCollection 2013 Jun.
- Results publication: PubMed 14696681Chen LL, Hsu SF, Wang MH, Chen CL, Lin YD, Lai JS. Use of acupressure to improve gastrointestinal motility in women after trans-abdominal hysterectomy. Am J Chin Med. 2003;31(5):781-90. doi: 10.1142/S0192415X03001466.
- Individual participant dataSharing planned: No. Our study has not been published yet
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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.
Di̇lek Soylu principal investigator
Kahramanmaras Sutcu Imam universty
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 Gastrointestinal Dysfunction and Anxiety, run by Kahramanmaras Sutcu Imam 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 8 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 28 Oct 2020. 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 in the first flatus process according to the information received from the patient (time frame: Postoperative 0 and 72 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?
On the ClinicalTrials.gov record for NCT04606485, which also lists 4 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 28 Oct 2020.