Effects of Cranial Massage in Menopausal Women

NCT03565952 | Completed

• 1 other identifier: ID0020
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

INTRODUCTION Menopause is one more stage in a woman's life. The hormonal change is associated with a series of symptoms that usually manifest around 50 years. Not all women manifest all the symptoms or with the same intensity. The most common symptoms are: hot flushes and night sweats, changes in mood, insomnia or difficulty sleeping, weight gain, vaginal dryness and / or urinary problems; what is detrimental to the well-being of women. At this stage the woman feels more discouraged than usual, and may show moments of anxiety, stress or irritability with the people around her. Sleep disturbances can also cause a state of tiredness and excessive sleepiness during the day, or even persistent headaches that interfere with the daily routine could improve some of these aspects related to sleep disturbances and thus the quality of life of the woman. The objectives of this study are to know the effect of cranial therapeutic massage on insomnia, in order to improve the quality of life and the woman's corporal satisfaction, and to promote a better functioning and performance of the activities of daily life. MATERIAL AND METHODS In this study, the investigators selected women aged between 45 and 60 years, who presented changes and symptoms characteristic of the menopausal period, accompanied by alterations in sleep. In addition, the inclusion criteria require that women have not had a menstrual period for one year. Exclusion criteria are excessive stress, the use of medications to promote sleep and some type of contraindication to receive treatment. Protocol design It consists of a randomized clinical trial, with a total of 50 participants (n = 50), divided into a control group (n = 25) and an experimental group (n = 25). Intervention The experimental group is subjected to 1 session per week of manual cranial therapy consisting of massage and cranial relaxing techniques, with a duration of 30 minutes each session approximately, for 3 weeks and one month follow-up. Manual therapy consists of a prone and supine cranial massage. The control group does not receive treatment, but they will be evaluated the same as the experimental group. Evaluations Clinical interview Includes anthropometric data (age, weight and height). The quality of life questionnaire Sf-36 and the Menopause Rating Scale (MRS) that assesses the state of well-being of the menopausal woman through 11 simple answer questions. The Pittsburg Quality of Sleep Questionnaire (PSQI) takes sleep habits into account during the last month. The PSQI contains a total of 19 questions, grouped into 10 questions. In all cases, a score of 0 would indicate ease of sleeping, while a score of 3 would be a severe difficulty. On the other hand, the Sleep Journal also evaluates sleep habits, characteristics and sleep quality, but unlike the previous one, this questionnaire has to be answered daily by the patients. The Perceived Stress Scale (PSS) is composed of 14 questions that relate to the level of stress perceived during the last month; The higher the score of each question, the higher the level of stress the person has. The Body Satisfaction Questionnaire. 10 questions is which must be answered according to the state of health that best describes the person at that time. The Patient Global Impression of Change Scale questionnaire assesses the sensation of change, in terms of quality of life and sleep, functionality and limitation to perform the activities of daily life, which the participant has experienced since the beginning of the treatment of this study. Analysis of data The data obtained will be stored in a database (SPSS), with which the analysis of the data will also be performed.

Conditions

Menopausal Women

Keywords

Menopausal women; Insomnia

Outcome Measures

Primary Outcomes (1)

• Quality of Sleep

  Pittsburg Quality of Sleep Questionnaire (PSQI). The Pittsburg Quality of Sleep Questionnaire (PSQI) takes sleep habits into account during the last month. The PSQI contains a total of 19 questions, grouped into 10 questions. In all cases, a score of 0 would indicate ease of sleeping, while a score of 3 would be a severe difficulty.

  8 week

Secondary Outcomes (5)

• Health status

  8 week

• Climacteric symptoms

  8 week

• Body Satisfaction

  8 week

• Perceived Stress

  8 week

• Global Impression of Change

  8 week

Study Arms (2)

Cranial massage

EXPERIMENTAL

Manual cranial therapy consisting of massage and cranial relaxing techniques, lasting 30 minutes each session approximately, for 3 weeks and one month follow-up. Manual therapy consists of a prone and supine cranial massage.

Other: Cranial massage

Control Group

ACTIVE COMPARATOR

The control group does not receive treatment.

Other: Control group

Interventions

Cranial massage OTHER

Manual cranial therapy consisting of massage and cranial relaxing techniques, lasting 30 minutes each session approximately, for 3 weeks and one month follow-up. Manual therapy consists of a prone and supine cranial massage.

Cranial massage

Control group OTHER

The control group does not receive treatment

Control Group

Eligibility Criteria

• Age: 45 Years - 60 Years
• Gender Eligibility Details: Menopausal women with insomnia
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• women from 45 to 60 years old
• who have not experienced any menstrual cycle for at least one year.
• showing clear menopausal symptoms.

You may not qualify if:

• that participants have not used more than twice a week of medication to promote sleep.
• that present contraindications to receive the treatment.

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Faculty of Physiotherapy

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 30, 2018
• First Posted: June 21, 2018
• Study Start: May 30, 2018
• Primary Completion: July 31, 2018
• Study Completion: August 15, 2018
• Last Updated: August 20, 2018

Record last verified: 2018-08

Locations

ES (1)