Hot FlashesNCT07419542
Effect of High Power Laser Acupuncture on Post Menopausal Hot Flashes
A study testing High power laser acupuncture and Paced Respiration Exercise in people with Hot Flashes, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study will be to determine the effect of high power laser acupuncture on post menopausal hot flashes. Read more about this study
- Who is it for?
- Ages 50 to 60 years, women only
- Conditions the study is for
- Hot Flashes
- What is being tested?
- High power laser acupuncture and Paced Respiration Exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2026to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- Breast cancer.
- Myocardial infarction.
- Pulmonary embolism.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Soheir Mahmoud El-Kosery, PhD contact
Egypt1 site
El Agoza police hospital
Cairo
Eman Saeed Mohamed Elgohary, M.Sc, +20 11 55883130, emanelgohary1982@icloud.com
About this study
The aim of this study will be to determine the effect of high power laser acupuncture on post menopausal hot flashes.
Read the 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.
- Conditions
- Hot Flashes
- Being tested
- High power laser acupuncture, Placebo High power laser acupuncture, Paced Respiration Exercise
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High power laser acupunctureDevice
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.
Placebo High power laser acupunctureOther
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.
Paced Respiration ExerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| High power laser acupuncture + Paced respiration exercise | Experimental | This group will consist of 30 postmenopausal women, who will receive High power laser acupuncture and paced respiration exercise for 15 minutes/sessions, 3 times/week for 4 weeks. Receives: Device: High power laser acupuncture; Other: Paced Respiration Exercise |
| Placebo High power laser acupuncture + Paced respiration exercise | Placebo comparator | This group will consist of 30 post menopausal women, who will receive placebo High power laser acupuncture and paced respiration exercise for 15 minutes /sessions, 3 times/ week for 4 weeks. Receives: Other: Placebo High power laser acupuncture; Other: Paced Respiration Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient reported hot flashes questionnaire
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.
Measured: 4 weeks
Secondary outcomes (1)
Follicular stimulating hormone analysis
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start20 Feb 2026 (estimated)
- Primary completion20 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hot FlashesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Saeed Mohamed Elgohary, Cairo University
- Investigators
- Soheir Mahmoud El-Kosery, PhD, Study chair, Professor, Cairo UniversityMohamed Fawzy Abu-Elenin, PhD, Study director, Consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07419542
- Sponsor's protocol ID
- P.T.REC/012/005136
- Status last verified
- Feb 2026
- First submitted
- 12 Feb 2026
- Last updated
- 19 Feb 2026
- 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 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High Power Laser Acupuncture on Post Menopausal Hot Flashes
- ClinicalTrials.gov ID
- NCT07419542
- Acronym / sponsor ID
- P.T.REC/012/005136
- Conditions
- Hot Flashes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Feb 2026 (estimated)
- Primary completion
- 20 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 19 Feb 2026 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High power laser acupuncture + Paced respiration exercise | Experimental | Device: High power laser acupuncture, Other: Paced Respiration ExerciseThis group will consist of 30 postmenopausal women, who will receive High power laser acupuncture and paced respiration exercise for 15 minutes/sessions, 3 times/week for 4 weeks. |
| Placebo High power laser acupuncture + Paced respiration exercise | Placebo comparator | Other: Placebo High power laser acupuncture, Other: Paced Respiration ExerciseThis group will consist of 30 post menopausal women, who will receive placebo High power laser acupuncture and paced respiration exercise for 15 minutes /sessions, 3 times/ week for 4 weeks. |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (3 listed)
- Breast cancer.
- Myocardial infarction.
- Pulmonary embolism.
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 |
|---|---|---|
| High power laser acupunctureParticipants 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. | Device | High power laser acupuncture + Paced respiration exercise |
| Placebo High power laser acupunctureParticipants 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. | Other | Placebo High power laser acupuncture + Paced respiration exercise |
| Paced Respiration ExerciseAll 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. | Other | High power laser acupuncture + Paced respiration exercise, Placebo High power laser acupuncture + Paced respiration exercise |
Primary outcome
Patient reported hot flashes questionnaire
Time frame: 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.
1 secondary outcome
Follicular stimulating hormone analysis
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
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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.
Soheir Mahmoud El-Kosery, PhD contact
Soheir Mahmoud El-Kosery, PhD study chair
Professor, Cairo University
Mohamed Fawzy Abu-Elenin, PhD study director
Consultant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High power laser acupuncture and Paced Respiration Exercise in people with Hot Flashes, run by Cairo University at 1 site in Egypt.
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 3 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: opening soon, as of the sponsor's last update on 19 Feb 2026. 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eman Saeed Mohamed Elgohary, M.Sc (+20 11 55883130, emanelgohary1982@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient reported hot flashes questionnaire (time frame: 4 weeks). 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 19 Feb 2026.