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

Not Applicable

Completed

• Conditions: Hysterectomy
• Interventions: Procedure: Abdominal or diaphragmatic breathing exercises; Procedure: Basic and light cervical mobilization exercises

• Registration Number: NCT05959785
• Lead Sponsor: University of Seville

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-02
• Study First Submitted: 2023-03-30
• Study First Submitted QC: 2023-07-17
• Study First Posted: 2023-07-25
• Primary Completion: 2024-06-15
• Status Verified: 2025-02
• Study Completion: 2025-02-10
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 74

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention group	Abdominal or diaphragmatic breathing exercises	Assignment to the intervention group will be done by simple randomization of the sample. A random sequence of numbers will be generated using the statistical program SPSS v.28. Patients will be included in the intervention group of each subcategory if their subject number matches one of the random numbers generated.The intervention groups will receive an explanatory video where a study collaborator performs a series of abdominal or diaphragmatic breathing exercises, which are intended to assess their effectiveness in this clinical trial.
control groups	Basic and light cervical mobilization exercises	The patients belonging to the control groups of each subcategory will also receive an explanatory video with basic and light cervical mobilization exercises (Annex 12). This group of exercises will be made up of a series of cervical mobilization exercises that are performed without pain, smooth, controlled by the patients, and without forcing the angulations. They are performed seated, with the arms extended along the body and forearms and hands resting on the legs. The chair must be firm and comfortable. Head movements to the right and left, right and left lateral flexion of the cervical region, cervical flexion and extension will be performed. This exercise will be performed for 5 minutes 3 times a day and beginning in the first 24 postoperative hours.

Primary Outcome Measures

Name	Time	Method
The Quick Dash quiz	24 hours after laparoscopy	Questionnaire containing questions about symptoms and the ability to use instruments of the upper limbs. Collect data referring to the last week
The McGill Pain Questionnaire	24 hours after laparoscopy	Location of pain: which is usually represented by a schematic figure of the human body, where the patient points out the areas where they feel pain.; * Quality of pain: the patient must choose from a wide list of types of pain those characteristics that define the one he presents. They are grouped into various categories that in turn form four large groups: sensory, emotional, evaluative and miscellaneous. In the original English version, the number of words was 78, although they may vary in the different validations of the questionnaire (66 in the Spanish version).; * Pain intensity at the current moment: explored by means of a question with five possible response categories.; * Assessment of pain at the current time using a visual analogue scale, ranging from "no pain" to "unbearable pain".
The Brief Pain Questionnaire	24 hours after laparoscopy	This questionnaire, in its short version, includes a body map that the patient can use to mark the areas where pain is located. In addition to providing a useful tool for localizing pain, this questionnaire provides important information about other characteristics of pain, as well as response to prescribed treatments.
The Neck Disability Index questionnaire	24 hours after laparoscopy	assesses neck and back pain and its influence on basic activities of daily living
The HIT-6 scale	24 hours after laparoscopy	evaluates the headache through 6 questions

Trial Locations

Locations (2)

Hospital Universitario Virgen del Rocío; 🇪🇸 Sevilla, Spain

Quiron Sagrado Corazon; 🇪🇸 Sevilla, Spain