Effects of Reflexology and Generalized Stretching in Postmenopausal Females.

NCT06303297 | Completed

• 1 other identifier: REC/RCR&AHS/23/0576
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postmenopausal Disorder

Keywords

Female; insomnia; postmenopausal; quality of life; reflexology

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

REFLEXOLOGY

EXPERIMENTAL

Other: REFLEXOLOGY

GENERALIZED STRETCHING

ACTIVE COMPARATOR

Other: GENERALIZED STRETCHING

Interventions

REFLEXOLOGY OTHER

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.

REFLEXOLOGY

GENERALIZED STRETCHING OTHER

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

GENERALIZED STRETCHING

Eligibility Criteria

• Age: 50 Years - 65 Years
• Gender Eligibility Details: post partum females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Akhtar Saeed trust hospital,

Lahore, Punjab Province, 05499, Pakistan

Location

Related Publications (7)

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

  BACKGROUND

• Hoare BS, Mikes BA, Khan YS. Anatomy, Abdomen and Pelvis: Female Internal Genitals. 2025 Feb 18. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK554601/

  PMID: 32119488 BACKGROUND

• 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.

  PMID: 37047549 BACKGROUND

• 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.

  PMID: 35382992 BACKGROUND

• 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.

  PMID: 35312401 BACKGROUND

• 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.

  PMID: 33088741 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• hina gul

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 12, 2024
• Study Start: November 23, 2023
• Primary Completion: August 10, 2024
• Study Completion: August 19, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)