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

NCT ID: NCT05959785

Last Updated: 2025-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-02
• Study Completion Date: 2025-02-10

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.

Conditions

Hysterectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

intervention group

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.

Group Type: EXPERIMENTAL

Abdominal or diaphragmatic breathing exercises

Intervention Type: PROCEDURE

The first abdominal or diaphragmatic breathing exercises will be carried out in a lying position, with the back well supported on a comfortable and firm surface, and with hips and knees flexed and feet supported. The patients take deep breaths, taking air raising the abdomen towards the ceiling, without raising the back from the horizontal plane. During expiration the navel will lower posteriorly and rise towards the thoracic region. For the second abdominal or diaphragmatic breathing exercise, the patient is seated on a firm and comfortable surface, with hips and knees flexed and feet supported. An inspiratory movement will be made in which the patient's navel will be moved outward, away from the spine. During expiration, the navel will go in the direction of the patient's spine and will rise in the direction of the thorax.

control groups

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.

Group Type: PLACEBO_COMPARATOR

Basic and light cervical mobilization exercises

Intervention Type: PROCEDURE

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.

Interventions

Basic and light cervical mobilization exercises

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.

Intervention Type: PROCEDURE

Abdominal or diaphragmatic breathing exercises

The first abdominal or diaphragmatic breathing exercises will be carried out in a lying position, with the back well supported on a comfortable and firm surface, and with hips and knees flexed and feet supported. The patients take deep breaths, taking air raising the abdomen towards the ceiling, without raising the back from the horizontal plane. During expiration the navel will lower posteriorly and rise towards the thoracic region. For the second abdominal or diaphragmatic breathing exercise, the patient is seated on a firm and comfortable surface, with hips and knees flexed and feet supported. An inspiratory movement will be made in which the patient's navel will be moved outward, away from the spine. During expiration, the navel will go in the direction of the patient's spine and will rise in the direction of the thorax.

Intervention Type: PROCEDURE

Other Intervention Names

Control group; Intervention group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Seville

OTHER

Sponsor Role: lead

Responsible Party

Antonio Luis Partida Márquez

Diplomado en Enfermería

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Universitario Virgen del Rocío

Seville, Sevilla, Spain

Quiron Sagrado Corazon

Seville, Sevilla, Spain

Countries

Spain

Other Identifiers

ALPM21

Identifier Type: -

Identifier Source: org_study_id