Clinical trial NCT06862986: Ear Massage Effect on Bowel Activity After Surgery
Official title: The Effect of Ear Massage on Bowel Activity in Patients Undergoing Lower Extremity Surgery: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Constipation
Lower Extremity Surgery
Keywords: Ear massage
lower extremity surgery
constipation
bowel activity
Lead sponsor: Mersin University
Sponsor class: OTHER
First posted: 2025-03-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Intervention model description: Prospective, parallel, Two-arm, randomized controlled clinical trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: Constipation is seen in patients undergoing orthopedic surgical interventions at rates as high as 23% to 94%. Constipation develops more frequently in individuals undergoing major orthopedic surgical interventions such as lower extremity arthroplasties and lower extremity fracture repairs. 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 after surgical intervention, increasing intestinal peristalsis and emptying the intestinal contents. The ear both contains its own unique points and is directly or indirectly connected to 12 body meridians. Massage applied to the ear provides balance between vital energy (qi) and blood flow (yin-yang) (12). The qi of the person stimulated by massaging these points in the ear is connected to certain organs such as the intestines through channels or meridians. Thanks to this connection, bowel movements can be stimulated and constipation can be eliminated. Ear massage has the potential to be an effective non-pharmacological method for the relief of gastrointestinal problems such as constipation.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time for the return of the bowel sound
timeFrame: Up to three days
measure: First defecation time after surgery
timeFrame: Up to three days
Secondary outcomes:
measure: the number of bowel sounds
timeFrame: up to three days
measure: use of defecation aids
timeFrame: up to three days
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Mersin University
state: Yenişehir
Study officials:
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