Clinical trial NCT03565952: Effects of Cranial Massage in Menopausal Women
Official title: Effects of Cranial Massage in Menopausal Women With Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopausal Women
Keywords: Menopausal women
Insomnia
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2018-06-21
Enrollment: 50
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Quality of Sleep
timeFrame: 8 week
Secondary outcomes:
measure: Health status
timeFrame: 8 week
measure: Climacteric symptoms
timeFrame: 8 week
measure: Body Satisfaction
timeFrame: 8 week
measure: Perceived Stress
timeFrame: 8 week
measure: Global Impression of Change
timeFrame: 8 week
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Faculty of Physiotherapy
Study officials:
References: