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

Hysterectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05959785
• Other study ID #: ALPM21
• Status: Recruiting
• Phase: N/A
• Start date: July 17, 2023
• Est. completion date: December 30, 2023

Study information

• Verified date: July 2023
• Source: University of Seville
• Contact: Antonio Luis Partida Márquez
• Phone: 652985005
• Email: apmolvera[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hysterectomy
• Pain, Referred

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
Spain	Hospital Universitario Virgen del Rocío	Sevilla
Spain	Quiron Sagrado Corazon	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
University of Seville

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The McGill Pain Questionnaire	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".	24 hours after laparoscopy
Primary	The Brief Pain Questionnaire	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.	24 hours after laparoscopy
Primary	The Quick Dash quiz	Questionnaire containing questions about symptoms and the ability to use instruments of the upper limbs. Collect data referring to the last week	24 hours after laparoscopy
Primary	The HIT-6 scale	evaluates the headache through 6 questions	24 hours after laparoscopy
Primary	The Neck Disability Index questionnaire	assesses neck and back pain and its influence on basic activities of daily living	24 hours after laparoscopy