Menopausal WomenCM-MWinNCT03565952
Effects of Cranial Massage in Menopausal Women
A study testing Cranial massage in people with Menopausal Women, run by University of Valencia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopausal Women
- What is being tested?
- Cranial massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 30 May 2018to 15 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- women from 45 to 60 years old
- who have not experienced any menstrual cycle for at least one year.
- showing clear menopausal symptoms.
Who cannot join
- that participants have not used more than twice a week of medication to promote sleep.
- that present contraindications to receive the treatment.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Cranial massage, Control group
- Keywords
- Menopausal women, Insomnia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cranial massageOther
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.
Control groupOther
The control group does not receive treatment
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Cranial massage |
| Control Group | Active comparator | The control group does not receive treatment. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 week
Secondary outcomes (5)
Health status
SF-36 is a health questionnaire, both physical and metal. It contains 36 items comprising 8 health status sub-scales. It includes different dimensions (Bodily Pain, Perceptions, Mental Health, Physical Function, Role-physical, Role-emotional, Social Function, and Vitality). Positive and negative health statuses are assessed. To evaluate each dimension, the items are transformed on a scale from 0 to 100. The result is obtained by summation of all the questions, in which 0 is the worst and 100 the best result and state of health.
Measured: 8 week
Climacteric symptoms
The Menopause Rating Scale (MRS) assesses the severity of climacteric symptoms. It consists of 11 symptoms divided into three groups: 1. MRS somatic level, includes: hot flashes, sweating, heart discomfort, sleep disturbances and joint and muscle discomfort; 2. Psychological MRS: depressive mood, irritability, anxiety and physical and mental fatigue; 3. Urogenital MRS: sexual problems, problems with urine and vaginal dryness.
It is an easy-to-complete questionnaire, in which each participant must attribute to each clinical manifestation a score of 0 to 4, depending on whether he or she experiences the described symptoms with greater or lesser intensity. The total MRS score is the sum of the scores obtained in each block.
Measured: 8 week
Body Satisfaction
Body Satisfaction and global self-perception Questionnaire. It contains 10 positive and 10 negative adjectives about the participant's body sensation with alternative answers ranging from 1 = Excellent to 5 = Poor. Each question is scored independently.
Measured: 8 week
Perceived Stress
Perceived Stress Scale (PSS). It consists of 14 questions that relate to the level of perceived stress during the last month. Each item has a score of 0 to 4 (0 = never, 1 = almost never, 2 = occasionally, 3 = often, 4 = very often). The total PSS score is the sum of the results of each item, which indicates that the higher the score attributed to each question, the higher the level of stress that the person presents.
Measured: 8 week
Global Impression of Change
Patient Global Impression of Change Scale, published by Hurst H. and Bolton J. Evaluates the sensation of change after the treatment received. It contains 7 affirmations (1 = I have improved a lot, 2 = I have improved a lot, 3 = I have improved a little, 4 = I am the same, 5 = I have worsened a little, 6 = I have worsened a lot, 7 = I have worsened a lot), together with an analog scale on the degree of change (0 = much better, 5 = no change, 10 = much worse).
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2018
- Study start30 May 2018
- Primary completion31 Jul 2018
- Study completion15 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menopausal WomenStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GEMMA V ESPÍ LÓPEZ, PhD, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03565952
- Sponsor's protocol ID
- ID0020
- Acronym
- CM-MWin
- Status last verified
- Aug 2018
- First submitted
- 30 May 2018
- Last updated
- 20 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cranial Massage in Menopausal Women With Insomnia
- ClinicalTrials.gov ID
- NCT03565952
- Acronym / sponsor ID
- CM-MWin / ID0020
- Conditions
- Menopausal Women
- Keywords
- Menopausal women, Insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 30 May 2018 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 15 Aug 2018 (actual)
- First posted
- 21 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cranial massage | Experimental | Other: Cranial massageManual 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. |
| Control Group | Active comparator | Other: Control groupThe control group does not receive treatment. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- women from 45 to 60 years old
- who have not experienced any menstrual cycle for at least one year.
- showing clear menopausal symptoms.
Key exclusion criteria (2 listed)
- that participants have not used more than twice a week of medication to promote sleep.
- that present contraindications to receive the treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cranial massageManual 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 groupThe control group does not receive treatment | Other | Control Group |
Primary outcome
Quality of Sleep
Time frame: 8 week
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.
5 secondary outcomes
Health status
Time frame: 8 week
Climacteric symptoms
Time frame: 8 week
Body Satisfaction
Time frame: 8 week
Perceived Stress
Time frame: 8 week
Global Impression of Change
Time frame: 8 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cranial massage in people with Menopausal Women, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Sleep (time frame: 8 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2018.