NCT06862986

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 7, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

September 10, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2025

Completed
Last Updated

December 5, 2025

Status Verified

December 1, 2025

Enrollment Period

3 months

First QC Date

March 5, 2025

Last Update Submit

December 4, 2025

Conditions

Keywords

Ear massagelower extremity surgeryconstipationbowel activity

Outcome Measures

Primary Outcomes (2)

  • 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).

    Up to three days

  • 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).

    Up to three days

Secondary Outcomes (2)

  • the number of bowel sounds

    up to three days

  • use of defecation aids

    up to three days

Study Arms (2)

Control group

NO INTERVENTION

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

Ear massage group

EXPERIMENTAL

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.

Other: Ear massage

Interventions

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.

Ear massage group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mersin University

Mersin, Yenişehir, 33010, Turkey (Türkiye)

Location

Related Publications (9)

  • 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

    RESULT
  • 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.

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
When the research is completed, the data will be transferred to the computer environment by a statistician who does not know the A and B groups, and the data will be analyzed by a statistician independent of the research and the findings will be reported.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Prospective, parallel, Two-arm, randomized controlled clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD , Department of Public Health Nursing, Principal investigator, Assoc. Prof. Dr.

Study Record Dates

First Submitted

March 5, 2025

First Posted

March 7, 2025

Study Start

September 10, 2025

Primary Completion

December 1, 2025

Study Completion

December 4, 2025

Last Updated

December 5, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

In order to avoid duplication, it is not intended to be shared until the research is completed.

Locations