Hot Flashes
Conditions
Brief summary
The aim of this study will be to determine the effect of high power laser acupuncture on post menopausal hot flashes.
Detailed description
There are several conflicting reports surrounding the efficacy of acupuncture for hot flashes, and several reviews exist. For example, in 2009 there were 2 reviews of acupuncture for hot flashes was performed. One evaluated 6 randomized controlled trials conducted in women without cancer. The second evaluated 6 randomized controlled trials performed in women with breast cancer. Conclusions in 2 reviews were that existing studies suffered from methodological weaknesses, major limitation of our study due to the small size of the group, the psycho physiological, social and culture level of each woman. and there was an overall lack of supporting evidence for the use of acupuncture for the treatment of hot flashes in these population. From previous studies , there was lack studies about effect of acupuncture on postmenopausal hot flashes. So this study end to investigate the effect of high power laser acupuncture on postmenopausal hot flashes.
Interventions
DEVICEHigh power laser acupuncture
Participants will lie supine while receiving high-power laser therapy (1064 nm wavelength, 150 mJ max pulse energy, 6 W average power, 760 mJ/cm² frequency, \<150 ms pulse duration). A pulsed waveform (5000 W/cm², 1 W output, 0.2 cm² spot size) will be applied perpendicularly to acupuncture points for 30 s (×3), totaling 15 min/session. Sessions: 3×/week for 4 weeks. Paced respiration exercises will also be performed for 15 min/session over the same period.
OTHERPlacebo High power laser acupuncture
Participants assigned to the placebo group will receive sham high-power laser therapy following the same treatment protocol used in the active intervention group, including identical positioning, probe placement, session duration, and frequency. The laser device will appear operational; however, it will be switched off during application and will not emit therapeutic laser energy. Sessions will last 15 minutes, three times per week, for four consecutive weeks.
OTHERPaced Respiration Exercise
All participants in both groups will perform paced respiration exercises during each treatment session. The exercise will consist of slow, controlled breathing at a predetermined rhythm, emphasizing diaphragmatic inhalation and prolonged exhalation. Breathing cycles will be guided verbally or by timing cues to maintain a consistent rate throughout the 15-minute session. The exercise will be performed three times per week for four consecutive weeks under supervision.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Sixty post menopausal women suffering from hot flashes. * Their age will range from 50 to 60 years. * Their body mass index (BMI) will range(\> 30kg/m2).
Exclusion criteria
* Breast cancer. * Myocardial infarction. * Pulmonary embolism.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient reported hot flashes questionnaire | 4 weeks | It will be used to determine the level of the hot flashes for each post menopausal women before starting as well as after the end of the study. Patient reported hot flashes questionnaire used to measure hot flashes frequency during the day and night .Hot flashes questionnaire score ranged from 0 (Not at all) to 10(very much). The numbers from 0 to 10 indicate the average amount of hot flashes which bothers the patient. This questionnaire include questions about number of hot flashes during day, number of hot flashes during night and duration of single hot flashes episode. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Follicular stimulating hormone analysis | 4 weeks | Participants will rest in a semi-recumbent position with proper back and arm support. The antecubital area will be disinfected with alcohol, and approximately 5 cubic centimeters of venous blood will be drawn from the antecubital vein using a sterile disposable syringe. Blood samples will be collected twice, before the start and after completion of the study. All samples will be obtained in the morning before breakfast to ensure standardization. |
Countries
Egypt
Contacts
CONTACTEman Saeed Mohamed Elgohary, M.Sc
CONTACTSoheir Mahmoud El-Kosery, PhD
STUDY_CHAIRSoheir Mahmoud El-Kosery, PhD
Professor, Cairo University
STUDY_DIRECTORMohamed Fawzy Abu-Elenin, PhD
Consultant
Outcome results
None listed