Effects of Reflexology and Generalized Stretching in Postmenopausal Females.

Postmenopausal Disorder Clinical Trial

Official title:

Combined Effects of Reflexology and Generalized Stretching on Insomnia, Vasomotor Symptoms and Quality of Life in Postmenopausal Females

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06303297
• Other study ID #: REC/RCR&AHS/23/0576
• Status: Recruiting
• Phase: N/A
• Start date: November 23, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: March 2024
• Source: Riphah International University
• Contact: imran amjad
• Phone: 03324390125
• Email: imran.amjad[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To determine the combined Effects of reflexology and generalized stretching on insomnia, vasomotor symptoms and quality of life in postmenopausal females

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: September 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 65 Years

Eligibility

Inclusion Criteria:

• BMI less than 30 kg/m2
• Residents of rural areas
• Stable vital signs
• Participants with natural cessation of menstrual periods for at least 12 months
• Moderate and severe hot flash

Exclusion Criteria:

• Participants with history of hysterectomy surgical menopause females
• Participants with orthopedic disorder
• Participants taking sleeping pills
• Women suffer from pathological conditions for example cardiac disease, cancer impaired skin integrity
• Participants with history of recent bone fracture
• Severe pathology(eczema) of feet

Related Conditions & MeSH terms

• Postmenopausal Disorder

Intervention

Other:
• REFLEXOLOGY
will receive foot and hand reflexology and stretching. The researcher will administer foot and hand reflexology to the participant for a period of 3 weeks this last for a duration of 10 min on each hand and foot with total duration of 40 minutes. Foot reflexology include general foot massage, including the foot rotation, Achilles stretching, and the foot extension and stretching, will be performed for a minute on each foot. In the right foot, the bottom of the heel will be kept with the left hand, and the metatarsal arch of the same foot will be held with the other hand. Then, the foot will be rotated clockwise and counter clockwise three times each direction. The same technique will be performed on the left foot. On hand lubricated with moisturizer to the dorsal and plantar surface and apply pressure on for 10 minutes. Noninvasive and safe complementary therapy that involves a direct pressure on specific body points connecting specific organs.
• GENERALIZED STRETCHING
will receive Stretching of upper and lower limbs. The stretching program lasts for 3 weeks with 60 min of stretching session 3 times a week. Extension of body include shoulder extension, torso rotation, hip extension, calf stretching (ankle pumps). ten stretches of 30 s each, with 15 s of rest between each stretch

Locations

Country	Name	City	State
Pakistan	Akhtar Saeed trust hospital,	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (7)

Hoare BS, Khan YS. Anatomy, Abdomen and Pelvis: Female Internal Genitals. 2023 Jul 24. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK554601/ — View Citation

Kalhan M, Singhania K, Choudhary P, Verma S, Kaushal P, Singh T. Prevalence of Menopausal Symptoms and its Effect on Quality of Life among Rural Middle Aged Women (40-60 Years) of Haryana, India. Int J Appl Basic Med Res. 2020 Jul-Sep;10(3):183-188. doi: 10.4103/ijabmr.IJABMR_428_19. Epub 2020 Jul 11. — View Citation

Ragasudha A, Minnu S, Kumar RS. Menopause Induced Depression, Anxiety, Quality of Life, Lack of Sleep in Women: An Overview. Journal of Drug Delivery and Therapeutics. 2021;11(6):319-23.

Sochocka M, Karska J, Pszczolowska M, Ochnik M, Fulek M, Fulek K, Kurpas D, Chojdak-Lukasiewicz J, Rosner-Tenerowicz A, Leszek J. Cognitive Decline in Early and Premature Menopause. Int J Mol Sci. 2023 Mar 31;24(7):6566. doi: 10.3390/ijms24076566. — View Citation

Talaulikar V. Menopause transition: Physiology and symptoms. Best Pract Res Clin Obstet Gynaecol. 2022 May;81:3-7. doi: 10.1016/j.bpobgyn.2022.03.003. Epub 2022 Mar 16. — View Citation

Vogazianou A. Anatomy and physiology of the female reproductive system. Advanced Practice in Endocrinology Nursing. 2019:739-52.

Yeo JH, Kim MT. Association of weight, smoking, and alcohol consumption with age at natural menopause. J Women Aging. 2023 Jul-Aug;35(4):343-353. doi: 10.1080/08952841.2022.2050157. Epub 2022 Mar 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insomnia severity index score	This questionnaire is a 7 items questionnaire which is used to assess sleep problems. It scoring is done through Likert type scale ranging from 0 to 4, where higher score represents higher sleep problem. Its score is range from 0 to 28 where 0 to 7 shows no clinically significant insomnia, 8 to 14 shows subthreshold insomnia, 15 to 21 shows moderate severity of insomnia and 22 to 28 shows severe severity of insomnia. It is a reliable and valid tool with internal consistency of 0.74 and correlation ranging from 0.36 to 0.54.	3rd week
Primary	Menopause Rating Scale	Menopause Rating Scale is a 11 items questionnaire which is use to assess vasomotor symptoms like hot flush, palpitations, sleep problem, bladder symptoms and other symptoms.; Its score range is from 0 to 4, where 0 shows no complain and 4 shows severe symptoms. Its total score range is from 9 to 21, where higher the score higher are the symptoms. It has good validity and reliability. It has Cronbach alpha value of 0.86 and internal consistency of 0.81.	3rd week
Primary	Menopause Specific Quality of Life	Menopause specific quality of life (MENQOL) questionnaire is a 29 items questionnaire which is used to assess quality of life among menopausal women. It has further four domains vasomotor (item 1 to 3), sexual (item 27-29), psychosocial (item 4-10) and physical (item 11 to 26). It is a reliable and valid tool with Cronbach value of 0.70 and internal consistency of 0.45.	3rd week