- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06862986
Ear Massage Effect on Bowel Activity After Surgery
The Effect of Ear Massage on Bowel Activity in Patients Undergoing Lower Extremity Surgery: A Randomized Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Constipation, which frequently develops after surgical intervention and is an undesirable problem, is seen at high rates ranging from 23% to 94% in patients undergoing orthopedic surgical intervention. This rate varies according to the type of surgical intervention performed and is higher especially in individuals undergoing major orthopedic surgical interventions such as lower extremity arthroplasties and lower extremity fracture repairs. Patients undergoing lower extremity surgery have mobility limitations before and after surgical intervention, prolonged fasting before surgical intervention, dietary changes, surgical intervention performed under general anesthesia, opioid/nonopioid analgesia used in pain management, inability to take the appropriate position for defecation, use of bedpan, and applications such as plaster, traction, joint prosthesis that cause limitation of movement cause constipation in patients. Constipation causes patients to face many physiologic and psychologic problems such as restlessness, abdominal tension, epigastric pain, diaphragmatic tension, hypotension, tachycardia and delays postoperative recovery.
Ear massage is one of the methods that is thought to be effective in preventing or reducing constipation that may develop in the early period by activating the parasympathetic nervous system, increasing intestinal peristalsis and emptying the intestinal contents after surgical intervention. Anatomically, the ear is an organ with dense vessels and nerves and the only peripheral branch of the vagus nerve is located in the outer ear. Stimulation of the points on the vagus nerve in the ear with ear massage can directly activate the parasympathetic nervous system. With the activation of the parasympathetic nervous system, the neural networks in the digestive system, especially the vagovagal neurocircuits, become more active. With the activation of vagovagal neurocircuits, the enteric nervous system (ENS), which provides independent functioning of the intestines and other gastrointestinal organs, is activated. The ENS, whose activation increases with this interaction, regulates electrical and chemical transmission in the digestive tract and helps the intestines to function more efficiently.
On the other hand, the ear is one of the most important organs in Traditional Chinese Medicine. The ear both contains its own specific points and is directly or indirectly connected to 12 body meridians. Massage applied to the ear ensures balance between vital energy (qi) and blood flow (yin-yang). The qi of the person stimulated by massaging these points in the ear is connected through channels or meridians to specific organs such as the intestines. This connection stimulates bowel movements and relieves constipation.
Ear massage has the potential to be an effective non-pharmacologic method for the relief of gastrointestinal problems such as constipation. Although there are studies in the literature showing that massages applied to different areas such as the abdomen in patients undergoing orthopedic surgery have a positive effect on gastrointestinal system functions, there is no study examining the effect of ear massage on the excretory activities of patients undergoing lower extremity surgery. Based on the aforementioned information, the aim of this study was to determine the effect of ear massage on excretory activities (return time of bowel sounds, time to first defecation, number of bowel sounds and number of laxative use) in patients undergoing lower extremity surgery, who were at high risk for the development of constipation after surgical intervention.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Yenişehir
-
Mersin, Yenişehir, Turkey (Türkiye), 33010
- Mersin University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Not signing the Informed Volunteer Consent Form,
- Under 18 years of age and over 65 years of age,
- Unconscious or having problems with orientation,
- Those who cannot speak Turkish and do not understand it,
- undergoing surgical intervention at sites other than the lower extremities,
- Physician-diagnosed chronic constipation or history of diseases that may affect intestinal peristalsis (inflammatory bowel disease, presence of abdominal tumor, surgical intervention or radiotherapy to the abdominal region, presence or suspicion of ileus, and pregnancy) and regular laxative users,
- Enemas administered before surgical intervention,
- Patients who have problems with the transition to oral feeding and who are unable to feed orally will be included in the study.
Exclusion Criteria:
- Not signing the Informed Volunteer Consent Form,
- Under 18 years of age and over 65 years of age,
- Unconscious or having problems with orientation,
- Those who cannot speak Turkish and do not understand it,
- undergoing surgical intervention at sites other than the lower extremities,
- Physician-diagnosed chronic constipation or history of diseases that may affect intestinal peristalsis (inflammatory bowel disease, presence of abdominal tumor, surgical intervention or radiotherapy to the abdominal region, presence or suspicion of ileus, and pregnancy) and regular laxative users,
- Enema administered before surgical intervention,
- Patients who have problems with transition to oral feeding and who cannot be fed orally will not be included in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
In the clinic where the study was conducted, patients who will undergo lower extremity surgery are placed on bed rest and restricted movement before surgical intervention and hospitalized in the clinic for approximately one day to ensure optimum preparation of the patient for surgery.
During this period, the constipation status of the patients before surgical intervention is evaluated and if the patients state that they are unable to defecate, an enema is administered to ensure defecation before surgical intervention.
After surgical intervention, patients are on absolute bed rest for 24 hours and their first mobilization is provided upon physician's request.
In this period, the first gas and defecation time of the patients are routinely recorded by the nurses in the ward, and enemas (sodium phosphate) and laxatives (lactulose) are administered to patients who do not have gas and defecation in the first 3 days after surgical intervention.
In the study, no procedure other than routine t
|
|
|
Experimental: Ear massage group
At least one Intervention must be specified for an Interventional study.
Patients included in the study group will receive ear massage in addition to the routine treatment and care practices of the clinic.
Ear massage application will be started in the evening of the first day after surgical intervention (at 19:30) and will be applied twice a day at least 30 minutes after morning and evening meals (07:30 am, 19:30 pm) for 3 minutes each, similar to the literature (8,9,12).
The bowel sounds of the patients will be re-evaluated before and 10 minutes after the ear massage application, and the excretory activities form will be filled out.
Ear massage application will be terminated when the patient defecates or when the patient is given an enema.
|
At least one Intervention must be specified for an Interventional study.
Patients included in the study group will receive ear massage in addition to the routine treatment and care practices of the clinic.
Ear massage application will be started in the evening of the first day after surgical intervention (at 19:30) and will be applied twice a day at least 30 minutes after morning and evening meals (07:30 am, 19:30 pm) for 3 minutes each, similar to the literature (8,9,12).
The bowel sounds of the patients will be re-evaluated before and 10 minutes after the ear massage application, and the excretory activities form will be filled out.
Ear massage application will be terminated when the patient defecates or when the patient is given an enema.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time for the return of the bowel sound
Time Frame: Up to three days
|
The time of the first return of the bowel sounds of the patients after the surgical intervention will be recorded by asking the researcher by asking twice a day (morning-evening).
|
Up to three days
|
|
First defecation time after surgery
Time Frame: Up to three days
|
The time of the patients' first defecation time after surgical intervention will be recorded by asking the investigator by asking twice a day (morning-evening).
|
Up to three days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the number of bowel sounds
Time Frame: up to three days
|
After the surgical intervention, the number of bowel sounds of the patients will be recorded twice a day (morning and evening) by the investigator.
|
up to three days
|
|
use of defecation aids
Time Frame: up to three days
|
After the surgical intervention, the patients' use of defecation aids will be recorded by the investigator by asking them twice a day (morning-evening).
|
up to three days
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Yue C, Liu Y, Zhang X, Xu B, Sheng H. Randomised controlled trial of a comprehensive protocol for preventing constipation following total hip arthroplasty. J Clin Nurs. 2020 Aug;29(15-16):2863-2871. doi: 10.1111/jocn.15299. Epub 2020 May 26.
- Jiang ZF, Liu G, Sun XX, Zhi N, Li XM, Sun R, Zhang H. Auricular acupressure for constipation in adults: a systematic review and meta-analysis. Front Physiol. 2023 Oct 16;14:1257660. doi: 10.3389/fphys.2023.1257660. eCollection 2023.
- Kuo SY, Tsai SH, Chen SL, Tzeng YL. Auricular acupressure relieves anxiety and fatigue, and reduces cortisol levels in post-caesarean section women: A single-blind, randomised controlled study. Int J Nurs Stud. 2016 Jan;53:17-26. doi: 10.1016/j.ijnurstu.2015.10.006. Epub 2015 Oct 22.
- Tseng YT, Chen IH, Lee PH, Lin PC. Effects of auricular acupressure on depression and anxiety in older adult residents of long-term care institutions: A randomized clinical trial. Geriatr Nurs. 2021 Jan-Feb;42(1):205-212. doi: 10.1016/j.gerinurse.2020.08.003. Epub 2020 Sep 11.
- Jing X, Liu J, Wang C, Ji M, Chen X, Mei Y, Zhu QR. Auricular acupressure is an alternative in treating constipation in leukemia patients undergoing chemotherapy: A systematic review and meta-analysis. Complement Ther Clin Pract. 2018 May;31:282-289. doi: 10.1016/j.ctcp.2018.03.005. Epub 2018 Mar 14.
- Nouhi E, Mansour-Ghanaei R, Hojati SA, Chaboki BG. The effect of abdominal massage on the severity of constipation in elderly patients hospitalized with fractures: A randomized clinical trial. Int J Orthop Trauma Nurs. 2022 Nov;47:100936. doi: 10.1016/j.ijotn.2022.100936. Epub 2022 Feb 24.
- Seyyedrassoli, A., Ghahramanian, A., Azizi, A., Goljarian, S., Gillespie, M., & Aydinferd, S. (2018). Comparison of effectiveness of reflexology and abdominal massage on constipation among orthopedic patients: A single-blind randomized controlled trial. International Journal of Medical Research & Health Sciences, 5
- Lee TH, Lee JS, Hong SJ, Jang JY, Jeon SR, Byun DW, Park WY, Kim SI, Choi HS, Lee JC, Lee JS. Risk factors for postoperative ileus following orthopedic surgery: the role of chronic constipation. J Neurogastroenterol Motil. 2015 Jan 1;21(1):121-5. doi: 10.5056/jnm14077.
- G Rler H, Y Ld Z FT, Bekmez F. A Common Complication in Orthopedic Patients: Postoperative Constipation and Related Risk Factors. J Perianesth Nurs. 2023 Oct;38(5):e15-e20. doi: 10.1016/j.jopan.2023.05.004. Epub 2023 Aug 12.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EarMassageMersinU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Constipation
-
Peking Union Medical College HospitalInstitute of Process Engineering, Chinese Academy of SciencesNot yet recruitingChronic Constipation | Constipation - Functional | Fecal Microbiota TransplantationChina
-
Singapore Institute of TechnologyNot yet recruitingConstipation | Diet Modification | Constipation-predominant Irritable Bowel Syndrome | Diet Therapy | Constipation - Functional | Constipation Chronic Idiopathic | Constipation, Signs and Symptoms, Digestive | Dietary Fiber | Dietary Fibers | Constipation Predominant Irritable Bowel Syndrome | Dietary and... and other conditionsSingapore
-
Hamilton Health Sciences CorporationNot yet recruitingConstipation | Constipation - Functional | Constipation AggravatedCanada
-
Institute of Medical Sciences and SUM HospitalNot yet recruitingFunctional Constipation | Constipation - Functional | Constipation Chronic Idiopathic | Fecal Impaction | Pediatric Functional ConstipationIndia
-
Peking Union Medical College HospitalRecruitingChronic Constipation | Constipation - Functional | Fecal Microbiota Transplantation (FMT)China
-
SK Life Science, Inc.CompletedChronic Constipation | Functional ConstipationUnited States
-
Hong Kong Metropolitan UniversityNot yet recruitingConstipation | Constipation Drug Induced | Psychiatric Drug Induced ConstipationHong Kong
-
Hong Kong Metropolitan UniversityHospital Authority, Hong KongRecruitingConstipation | Constipation Drug Induced | Psychiatric Drug Induced ConstipationHong Kong
-
Cairo UniversityUnknownChronic Idiopathic Constipation | Functional ConstipationEgypt
-
usMIMA S.L.University of York; County Durham and Darlington NHS Foundation TrustCompletedConstipation | Constipation-predominant Irritable Bowel Syndrome | Constipation - Functional | Constipation Chronic Idiopathic | Constipation; NeurogenicUnited Kingdom
Clinical Trials on Ear massage
-
Mersin UniversityRecruitingStress | Anxiety | Sleep QualityTurkey
-
Mersin UniversityCompletedSleep Quality | Sleep PerceptionTurkey (Türkiye)
-
Hospital Authority, Hong KongUnknownCerumen Impaction of Both EarsHong Kong
-
Beijing Tiantan HospitalCompleted
-
National Yang Ming UniversityCompleted
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityCompletedEndoscopy; Microscopy; Ear Surgery; Cholesteatoma; Clinical Effect
-
Assiut UniversityUnknown
-
Medical University of GrazNot yet recruitingInsomnia | Oncology | Symptoms and SignsAustria
-
Taipei City HospitalNational Yang Ming UniversityCompleted
-
Fatima ElmougiCompletedEar Deformity ExternalEgypt