CompletedNot Applicable

Diaphragmatic Exercises As Treatment of Referred Pain After Total Laparoscopic Hysterectomy: Randomized Clinical Trial.

Spain74 participantsStarted 2023-02-02

Plain-language summary

Through a blinded clinical trial, the aim is to evaluate the efficacy of manual therapy in the treatment of pain referred to after laparoscopic hysterectomy. Control and intervention groups were randomly established. Informed consent will be requested for participation in the study.

Who can participate

Age range

18 Years – 65 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * • Patients who have given their consent to participate in the project by signing the informed consent. * Patient between 18 and 65 years of age. * Patients with a hysterectomy scheduled to be performed in less than 3 months at the Women's Hospital in Seville or at the Quirón Sagrado Corazón Clinic in Seville. * Who develops pain of intensity greater than 7 points located in the head, neck or upper limbs in the first 24 hours post-hysterectomy. * Patients who are able to communicate in Spanish or English. Exclusion Criteria: * Neurological Pathology. * Non-cooperative Subject. * Severe Psychiatric Illness. * Loss of Cognitive Capacity. * Evidence that post-hysterectomy pain is not caused by surgery (eg, presence of fracture or infection in the head, neck or upper limbs. * Localized pain in areas not considered in this study and that may affect the performance and results of the study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The McGill Pain Questionnaire

Timeframe: 24 hours after laparoscopy

The Brief Pain Questionnaire

Timeframe: 24 hours after laparoscopy

The Quick Dash quiz

Timeframe: 24 hours after laparoscopy

The HIT-6 scale

Timeframe: 24 hours after laparoscopy

The Neck Disability Index questionnaire

Timeframe: 24 hours after laparoscopy

Trial details

NCT IDNCT05959785

SponsorUniversity of Seville

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-15

View on ClinicalTrials.gov More Hysterectomy trials

Who can participate

Age range

18 Years – 65 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

The McGill Pain Questionnaire

Timeframe: 24 hours after laparoscopy

The Brief Pain Questionnaire

Timeframe: 24 hours after laparoscopy

The Quick Dash quiz

Timeframe: 24 hours after laparoscopy

The HIT-6 scale

Timeframe: 24 hours after laparoscopy

The Neck Disability Index questionnaire

Timeframe: 24 hours after laparoscopy