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

University of Seville

Status: Completed

Conditions: Hysterectomy

Treatments: Procedure: Abdominal or diaphragmatic breathing exercises; Procedure: Basic and light cervical mobilization exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT05959785

ALPM21

Details and patient eligibility

About

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.

Enrollment: 74 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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74 participants in 2 patient groups, including a placebo group

intervention group

Experimental group

Description:

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.

Treatment:

Procedure: Abdominal or diaphragmatic breathing exercises

control groups

Placebo Comparator group

Description:

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.

Treatment:

Procedure: Basic and light cervical mobilization exercises