Menopausal Women Clinical Trial
Official title:
Effects of Cranial Massage in Menopausal Women With Insomnia
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.
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