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ConstipationNCT06862986

Ear Massage Effect on Bowel Activity After Surgery

A study testing Ear massage in people with Constipation and Lower Extremity Surgery, run by Mersin University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Constipation, Lower Extremity Surgery
What is being tested?
Ear massage
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteTurkey (Türkiye)
Study dates
10 Sep 2025to 4 Dec 2025
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Mersin University

    Mersin, Yenişehir, 33010

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Ear Massage on Bowel Activity in Patients Undergoing Lower Extremity Surgery: A Randomized Controlled Study

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.

Read the 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.

Being tested
Ear massage
Keywords
Ear massage, lower extremity surgery, constipation, bowel activity
Medical subject headings
Constipation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ear massageOther

    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.

Study groups in NCT06862986
Study groupRoleWhat they receive
Control groupNo interventionIn 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
Ear massage groupExperimentalAt 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.
Receives: Other: Ear massage

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time for the return of the bowel sound

    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).

    Measured: Up to three days

  2. First defecation time after surgery

    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).

    Measured: Up to three days

Secondary outcomes (2)
  1. the number of bowel sounds

    After the surgical intervention, the number of bowel sounds of the patients will be recorded twice a day (morning and evening) by the investigator.

    Measured: up to three days

  2. use of defecation aids

    After the surgical intervention, the patients' use of defecation aids will be recorded by the investigator by asking them twice a day (morning-evening).

    Measured: up to three days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2025
  2. Study start10 Sep 2025
  3. Primary completion1 Dec 2025
  4. Study completion4 Dec 2025

Resources

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
Model description
Prospective, parallel, Two-arm, randomized controlled clinical trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06862986
Sponsor's protocol ID
EarMassageMersinU
Status last verified
Dec 2025
First submitted
5 Mar 2025
Last updated
5 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: In order to avoid duplication, it is not intended to be shared until the research is completed.

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.

    PubMed 32320100
  • 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.

    PubMed 37908337
  • 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.

    PubMed 26525188
  • 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.

    PubMed 32921508
  • 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.

    PubMed 29705469
  • 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.

    PubMed 36274468
  • 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.

    PubMed 25537675
  • 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.

    PubMed 37578408

Questions about this trial

What is this clinical trial studying?

A study testing Ear massage in people with Constipation and Lower Extremity Surgery, run by Mersin 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 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 5 Dec 2025. 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. 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?

Time for the return of the bowel sound (time frame: Up to three days). The study lists 2 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 NCT06862986, which also lists 9 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 5 Dec 2025.

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